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Postoperative Adjuvant Lapatinib and Concurrent Chemoradiotherapy Followed by Maintenance Lapatinib Monotherapy in High-Risk Patients With Resected Squamous Cell Carcinoma of the Head and Neck: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study.
Journal article

Postoperative Adjuvant Lapatinib and Concurrent Chemoradiotherapy Followed by Maintenance Lapatinib Monotherapy in High-Risk Patients With Resected Squamous Cell Carcinoma of the Head and Neck: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study.

  • Harrington K Kevin Harrington, Institute of Cancer Research and Royal Marsden Hospital, London; Hisham Mehanna, Institute of Head and Neck Studies and Education, University of Birmingham, Birmingham; Natalie Franklin and John Farrell, GlaxoSmithKline, Uxbridge, United Kingdom; Stephane Temam and Jean Bourhis, Institut Gustave- Roussy, Villejuif; Ida D'Onofrio, Hôpital Forcilles, Paris, France; Anil D'Cruz, Tata Memorial Hospital, Mumbai; Minish Jain, Ruby Hall Clinic-Cancer Centre, Pune, India; Georgy Manikhas, St Petersburg City Oncology Dispensary, St Petersburg, Russia; Zsuzsanna Horvath, Szent Imre University Teaching Hospital Budapest, Budapest, Hungary; Yan Sun, Beijing Cancer Hospital, Beijing, China; Stefan Dietzsch, Hospital and Policlinic for Radiation Therapy and Radio-oncology, Leipzig, Germany; Pavol Dubinsky, East Slovakia Cancer Institute, Kosice, Slovakia; Petra Holeckova, Institute of Radiation Oncology, Hospital Na Bulovce, and 1st Medical Faculty of Charles University, Prague, Czech Republic; Iman El-Hariry, Synta Pharmaceutical, Lexington, MA; Paul Wissel and Mayur Amonkar, Novartis Pharmaceuticals, East Hanover, NJ; Catherine Ellis and Sergio Santillana, GlaxoSmithKline, Philadelphia, PA; and Nigel Biswas-Baldwin, Philippe Legenne, Thelma Netherway, Jing Wang-Silvanto, and Nazma Ahmed, Novartis Pharma AG, Basel, Switzerland.
  • Temam S Kevin Harrington, Institute of Cancer Research and Royal Marsden Hospital, London; Hisham Mehanna, Institute of Head and Neck Studies and Education, University of Birmingham, Birmingham; Natalie Franklin and John Farrell, GlaxoSmithKline, Uxbridge, United Kingdom; Stephane Temam and Jean Bourhis, Institut Gustave- Roussy, Villejuif; Ida D'Onofrio, Hôpital Forcilles, Paris, France; Anil D'Cruz, Tata Memorial Hospital, Mumbai; Minish Jain, Ruby Hall Clinic-Cancer Centre, Pune, India; Georgy Manikhas, St Petersburg City Oncology Dispensary, St Petersburg, Russia; Zsuzsanna Horvath, Szent Imre University Teaching Hospital Budapest, Budapest, Hungary; Yan Sun, Beijing Cancer Hospital, Beijing, China; Stefan Dietzsch, Hospital and Policlinic for Radiation Therapy and Radio-oncology, Leipzig, Germany; Pavol Dubinsky, East Slovakia Cancer Institute, Kosice, Slovakia; Petra Holeckova, Institute of Radiation Oncology, Hospital Na Bulovce, and 1st Medical Faculty of Charles University, Prague, Czech Republic; Iman El-Hariry, Synta Pharmaceutical, Lexington, MA; Paul Wissel and Mayur Amonkar, Novartis Pharmaceuticals, East Hanover, NJ; Catherine Ellis and Sergio Santillana, GlaxoSmithKline, Philadelphia, PA; and Nigel Biswas-Baldwin, Philippe Legenne, Thelma Netherway, Jing Wang-Silvanto, and Nazma Ahmed, Novartis Pharma AG, Basel, Switzerland.
  • Mehanna H Kevin Harrington, Institute of Cancer Research and Royal Marsden Hospital, London; Hisham Mehanna, Institute of Head and Neck Studies and Education, University of Birmingham, Birmingham; Natalie Franklin and John Farrell, GlaxoSmithKline, Uxbridge, United Kingdom; Stephane Temam and Jean Bourhis, Institut Gustave- Roussy, Villejuif; Ida D'Onofrio, Hôpital Forcilles, Paris, France; Anil D'Cruz, Tata Memorial Hospital, Mumbai; Minish Jain, Ruby Hall Clinic-Cancer Centre, Pune, India; Georgy Manikhas, St Petersburg City Oncology Dispensary, St Petersburg, Russia; Zsuzsanna Horvath, Szent Imre University Teaching Hospital Budapest, Budapest, Hungary; Yan Sun, Beijing Cancer Hospital, Beijing, China; Stefan Dietzsch, Hospital and Policlinic for Radiation Therapy and Radio-oncology, Leipzig, Germany; Pavol Dubinsky, East Slovakia Cancer Institute, Kosice, Slovakia; Petra Holeckova, Institute of Radiation Oncology, Hospital Na Bulovce, and 1st Medical Faculty of Charles University, Prague, Czech Republic; Iman El-Hariry, Synta Pharmaceutical, Lexington, MA; Paul Wissel and Mayur Amonkar, Novartis Pharmaceuticals, East Hanover, NJ; Catherine Ellis and Sergio Santillana, GlaxoSmithKline, Philadelphia, PA; and Nigel Biswas-Baldwin, Philippe Legenne, Thelma Netherway, Jing Wang-Silvanto, and Nazma Ahmed, Novartis Pharma AG, Basel, Switzerland.
  • D'Cruz A Kevin Harrington, Institute of Cancer Research and Royal Marsden Hospital, London; Hisham Mehanna, Institute of Head and Neck Studies and Education, University of Birmingham, Birmingham; Natalie Franklin and John Farrell, GlaxoSmithKline, Uxbridge, United Kingdom; Stephane Temam and Jean Bourhis, Institut Gustave- Roussy, Villejuif; Ida D'Onofrio, Hôpital Forcilles, Paris, France; Anil D'Cruz, Tata Memorial Hospital, Mumbai; Minish Jain, Ruby Hall Clinic-Cancer Centre, Pune, India; Georgy Manikhas, St Petersburg City Oncology Dispensary, St Petersburg, Russia; Zsuzsanna Horvath, Szent Imre University Teaching Hospital Budapest, Budapest, Hungary; Yan Sun, Beijing Cancer Hospital, Beijing, China; Stefan Dietzsch, Hospital and Policlinic for Radiation Therapy and Radio-oncology, Leipzig, Germany; Pavol Dubinsky, East Slovakia Cancer Institute, Kosice, Slovakia; Petra Holeckova, Institute of Radiation Oncology, Hospital Na Bulovce, and 1st Medical Faculty of Charles University, Prague, Czech Republic; Iman El-Hariry, Synta Pharmaceutical, Lexington, MA; Paul Wissel and Mayur Amonkar, Novartis Pharmaceuticals, East Hanover, NJ; Catherine Ellis and Sergio Santillana, GlaxoSmithKline, Philadelphia, PA; and Nigel Biswas-Baldwin, Philippe Legenne, Thelma Netherway, Jing Wang-Silvanto, and Nazma Ahmed, Novartis Pharma AG, Basel, Switzerland.
  • Jain M Kevin Harrington, Institute of Cancer Research and Royal Marsden Hospital, London; Hisham Mehanna, Institute of Head and Neck Studies and Education, University of Birmingham, Birmingham; Natalie Franklin and John Farrell, GlaxoSmithKline, Uxbridge, United Kingdom; Stephane Temam and Jean Bourhis, Institut Gustave- Roussy, Villejuif; Ida D'Onofrio, Hôpital Forcilles, Paris, France; Anil D'Cruz, Tata Memorial Hospital, Mumbai; Minish Jain, Ruby Hall Clinic-Cancer Centre, Pune, India; Georgy Manikhas, St Petersburg City Oncology Dispensary, St Petersburg, Russia; Zsuzsanna Horvath, Szent Imre University Teaching Hospital Budapest, Budapest, Hungary; Yan Sun, Beijing Cancer Hospital, Beijing, China; Stefan Dietzsch, Hospital and Policlinic for Radiation Therapy and Radio-oncology, Leipzig, Germany; Pavol Dubinsky, East Slovakia Cancer Institute, Kosice, Slovakia; Petra Holeckova, Institute of Radiation Oncology, Hospital Na Bulovce, and 1st Medical Faculty of Charles University, Prague, Czech Republic; Iman El-Hariry, Synta Pharmaceutical, Lexington, MA; Paul Wissel and Mayur Amonkar, Novartis Pharmaceuticals, East Hanover, NJ; Catherine Ellis and Sergio Santillana, GlaxoSmithKline, Philadelphia, PA; and Nigel Biswas-Baldwin, Philippe Legenne, Thelma Netherway, Jing Wang-Silvanto, and Nazma Ahmed, Novartis Pharma AG, Basel, Switzerland.
  • D'Onofrio I Kevin Harrington, Institute of Cancer Research and Royal Marsden Hospital, London; Hisham Mehanna, Institute of Head and Neck Studies and Education, University of Birmingham, Birmingham; Natalie Franklin and John Farrell, GlaxoSmithKline, Uxbridge, United Kingdom; Stephane Temam and Jean Bourhis, Institut Gustave- Roussy, Villejuif; Ida D'Onofrio, Hôpital Forcilles, Paris, France; Anil D'Cruz, Tata Memorial Hospital, Mumbai; Minish Jain, Ruby Hall Clinic-Cancer Centre, Pune, India; Georgy Manikhas, St Petersburg City Oncology Dispensary, St Petersburg, Russia; Zsuzsanna Horvath, Szent Imre University Teaching Hospital Budapest, Budapest, Hungary; Yan Sun, Beijing Cancer Hospital, Beijing, China; Stefan Dietzsch, Hospital and Policlinic for Radiation Therapy and Radio-oncology, Leipzig, Germany; Pavol Dubinsky, East Slovakia Cancer Institute, Kosice, Slovakia; Petra Holeckova, Institute of Radiation Oncology, Hospital Na Bulovce, and 1st Medical Faculty of Charles University, Prague, Czech Republic; Iman El-Hariry, Synta Pharmaceutical, Lexington, MA; Paul Wissel and Mayur Amonkar, Novartis Pharmaceuticals, East Hanover, NJ; Catherine Ellis and Sergio Santillana, GlaxoSmithKline, Philadelphia, PA; and Nigel Biswas-Baldwin, Philippe Legenne, Thelma Netherway, Jing Wang-Silvanto, and Nazma Ahmed, Novartis Pharma AG, Basel, Switzerland.
  • Manikhas G Kevin Harrington, Institute of Cancer Research and Royal Marsden Hospital, London; Hisham Mehanna, Institute of Head and Neck Studies and Education, University of Birmingham, Birmingham; Natalie Franklin and John Farrell, GlaxoSmithKline, Uxbridge, United Kingdom; Stephane Temam and Jean Bourhis, Institut Gustave- Roussy, Villejuif; Ida D'Onofrio, Hôpital Forcilles, Paris, France; Anil D'Cruz, Tata Memorial Hospital, Mumbai; Minish Jain, Ruby Hall Clinic-Cancer Centre, Pune, India; Georgy Manikhas, St Petersburg City Oncology Dispensary, St Petersburg, Russia; Zsuzsanna Horvath, Szent Imre University Teaching Hospital Budapest, Budapest, Hungary; Yan Sun, Beijing Cancer Hospital, Beijing, China; Stefan Dietzsch, Hospital and Policlinic for Radiation Therapy and Radio-oncology, Leipzig, Germany; Pavol Dubinsky, East Slovakia Cancer Institute, Kosice, Slovakia; Petra Holeckova, Institute of Radiation Oncology, Hospital Na Bulovce, and 1st Medical Faculty of Charles University, Prague, Czech Republic; Iman El-Hariry, Synta Pharmaceutical, Lexington, MA; Paul Wissel and Mayur Amonkar, Novartis Pharmaceuticals, East Hanover, NJ; Catherine Ellis and Sergio Santillana, GlaxoSmithKline, Philadelphia, PA; and Nigel Biswas-Baldwin, Philippe Legenne, Thelma Netherway, Jing Wang-Silvanto, and Nazma Ahmed, Novartis Pharma AG, Basel, Switzerland.
  • Horvath Z Kevin Harrington, Institute of Cancer Research and Royal Marsden Hospital, London; Hisham Mehanna, Institute of Head and Neck Studies and Education, University of Birmingham, Birmingham; Natalie Franklin and John Farrell, GlaxoSmithKline, Uxbridge, United Kingdom; Stephane Temam and Jean Bourhis, Institut Gustave- Roussy, Villejuif; Ida D'Onofrio, Hôpital Forcilles, Paris, France; Anil D'Cruz, Tata Memorial Hospital, Mumbai; Minish Jain, Ruby Hall Clinic-Cancer Centre, Pune, India; Georgy Manikhas, St Petersburg City Oncology Dispensary, St Petersburg, Russia; Zsuzsanna Horvath, Szent Imre University Teaching Hospital Budapest, Budapest, Hungary; Yan Sun, Beijing Cancer Hospital, Beijing, China; Stefan Dietzsch, Hospital and Policlinic for Radiation Therapy and Radio-oncology, Leipzig, Germany; Pavol Dubinsky, East Slovakia Cancer Institute, Kosice, Slovakia; Petra Holeckova, Institute of Radiation Oncology, Hospital Na Bulovce, and 1st Medical Faculty of Charles University, Prague, Czech Republic; Iman El-Hariry, Synta Pharmaceutical, Lexington, MA; Paul Wissel and Mayur Amonkar, Novartis Pharmaceuticals, East Hanover, NJ; Catherine Ellis and Sergio Santillana, GlaxoSmithKline, Philadelphia, PA; and Nigel Biswas-Baldwin, Philippe Legenne, Thelma Netherway, Jing Wang-Silvanto, and Nazma Ahmed, Novartis Pharma AG, Basel, Switzerland.
  • Sun Y Kevin Harrington, Institute of Cancer Research and Royal Marsden Hospital, London; Hisham Mehanna, Institute of Head and Neck Studies and Education, University of Birmingham, Birmingham; Natalie Franklin and John Farrell, GlaxoSmithKline, Uxbridge, United Kingdom; Stephane Temam and Jean Bourhis, Institut Gustave- Roussy, Villejuif; Ida D'Onofrio, Hôpital Forcilles, Paris, France; Anil D'Cruz, Tata Memorial Hospital, Mumbai; Minish Jain, Ruby Hall Clinic-Cancer Centre, Pune, India; Georgy Manikhas, St Petersburg City Oncology Dispensary, St Petersburg, Russia; Zsuzsanna Horvath, Szent Imre University Teaching Hospital Budapest, Budapest, Hungary; Yan Sun, Beijing Cancer Hospital, Beijing, China; Stefan Dietzsch, Hospital and Policlinic for Radiation Therapy and Radio-oncology, Leipzig, Germany; Pavol Dubinsky, East Slovakia Cancer Institute, Kosice, Slovakia; Petra Holeckova, Institute of Radiation Oncology, Hospital Na Bulovce, and 1st Medical Faculty of Charles University, Prague, Czech Republic; Iman El-Hariry, Synta Pharmaceutical, Lexington, MA; Paul Wissel and Mayur Amonkar, Novartis Pharmaceuticals, East Hanover, NJ; Catherine Ellis and Sergio Santillana, GlaxoSmithKline, Philadelphia, PA; and Nigel Biswas-Baldwin, Philippe Legenne, Thelma Netherway, Jing Wang-Silvanto, and Nazma Ahmed, Novartis Pharma AG, Basel, Switzerland.
  • Dietzsch S Kevin Harrington, Institute of Cancer Research and Royal Marsden Hospital, London; Hisham Mehanna, Institute of Head and Neck Studies and Education, University of Birmingham, Birmingham; Natalie Franklin and John Farrell, GlaxoSmithKline, Uxbridge, United Kingdom; Stephane Temam and Jean Bourhis, Institut Gustave- Roussy, Villejuif; Ida D'Onofrio, Hôpital Forcilles, Paris, France; Anil D'Cruz, Tata Memorial Hospital, Mumbai; Minish Jain, Ruby Hall Clinic-Cancer Centre, Pune, India; Georgy Manikhas, St Petersburg City Oncology Dispensary, St Petersburg, Russia; Zsuzsanna Horvath, Szent Imre University Teaching Hospital Budapest, Budapest, Hungary; Yan Sun, Beijing Cancer Hospital, Beijing, China; Stefan Dietzsch, Hospital and Policlinic for Radiation Therapy and Radio-oncology, Leipzig, Germany; Pavol Dubinsky, East Slovakia Cancer Institute, Kosice, Slovakia; Petra Holeckova, Institute of Radiation Oncology, Hospital Na Bulovce, and 1st Medical Faculty of Charles University, Prague, Czech Republic; Iman El-Hariry, Synta Pharmaceutical, Lexington, MA; Paul Wissel and Mayur Amonkar, Novartis Pharmaceuticals, East Hanover, NJ; Catherine Ellis and Sergio Santillana, GlaxoSmithKline, Philadelphia, PA; and Nigel Biswas-Baldwin, Philippe Legenne, Thelma Netherway, Jing Wang-Silvanto, and Nazma Ahmed, Novartis Pharma AG, Basel, Switzerland.
  • Dubinsky P Kevin Harrington, Institute of Cancer Research and Royal Marsden Hospital, London; Hisham Mehanna, Institute of Head and Neck Studies and Education, University of Birmingham, Birmingham; Natalie Franklin and John Farrell, GlaxoSmithKline, Uxbridge, United Kingdom; Stephane Temam and Jean Bourhis, Institut Gustave- Roussy, Villejuif; Ida D'Onofrio, Hôpital Forcilles, Paris, France; Anil D'Cruz, Tata Memorial Hospital, Mumbai; Minish Jain, Ruby Hall Clinic-Cancer Centre, Pune, India; Georgy Manikhas, St Petersburg City Oncology Dispensary, St Petersburg, Russia; Zsuzsanna Horvath, Szent Imre University Teaching Hospital Budapest, Budapest, Hungary; Yan Sun, Beijing Cancer Hospital, Beijing, China; Stefan Dietzsch, Hospital and Policlinic for Radiation Therapy and Radio-oncology, Leipzig, Germany; Pavol Dubinsky, East Slovakia Cancer Institute, Kosice, Slovakia; Petra Holeckova, Institute of Radiation Oncology, Hospital Na Bulovce, and 1st Medical Faculty of Charles University, Prague, Czech Republic; Iman El-Hariry, Synta Pharmaceutical, Lexington, MA; Paul Wissel and Mayur Amonkar, Novartis Pharmaceuticals, East Hanover, NJ; Catherine Ellis and Sergio Santillana, GlaxoSmithKline, Philadelphia, PA; and Nigel Biswas-Baldwin, Philippe Legenne, Thelma Netherway, Jing Wang-Silvanto, and Nazma Ahmed, Novartis Pharma AG, Basel, Switzerland.
  • Holeckova P Kevin Harrington, Institute of Cancer Research and Royal Marsden Hospital, London; Hisham Mehanna, Institute of Head and Neck Studies and Education, University of Birmingham, Birmingham; Natalie Franklin and John Farrell, GlaxoSmithKline, Uxbridge, United Kingdom; Stephane Temam and Jean Bourhis, Institut Gustave- Roussy, Villejuif; Ida D'Onofrio, Hôpital Forcilles, Paris, France; Anil D'Cruz, Tata Memorial Hospital, Mumbai; Minish Jain, Ruby Hall Clinic-Cancer Centre, Pune, India; Georgy Manikhas, St Petersburg City Oncology Dispensary, St Petersburg, Russia; Zsuzsanna Horvath, Szent Imre University Teaching Hospital Budapest, Budapest, Hungary; Yan Sun, Beijing Cancer Hospital, Beijing, China; Stefan Dietzsch, Hospital and Policlinic for Radiation Therapy and Radio-oncology, Leipzig, Germany; Pavol Dubinsky, East Slovakia Cancer Institute, Kosice, Slovakia; Petra Holeckova, Institute of Radiation Oncology, Hospital Na Bulovce, and 1st Medical Faculty of Charles University, Prague, Czech Republic; Iman El-Hariry, Synta Pharmaceutical, Lexington, MA; Paul Wissel and Mayur Amonkar, Novartis Pharmaceuticals, East Hanover, NJ; Catherine Ellis and Sergio Santillana, GlaxoSmithKline, Philadelphia, PA; and Nigel Biswas-Baldwin, Philippe Legenne, Thelma Netherway, Jing Wang-Silvanto, and Nazma Ahmed, Novartis Pharma AG, Basel, Switzerland.
  • El-Hariry I Kevin Harrington, Institute of Cancer Research and Royal Marsden Hospital, London; Hisham Mehanna, Institute of Head and Neck Studies and Education, University of Birmingham, Birmingham; Natalie Franklin and John Farrell, GlaxoSmithKline, Uxbridge, United Kingdom; Stephane Temam and Jean Bourhis, Institut Gustave- Roussy, Villejuif; Ida D'Onofrio, Hôpital Forcilles, Paris, France; Anil D'Cruz, Tata Memorial Hospital, Mumbai; Minish Jain, Ruby Hall Clinic-Cancer Centre, Pune, India; Georgy Manikhas, St Petersburg City Oncology Dispensary, St Petersburg, Russia; Zsuzsanna Horvath, Szent Imre University Teaching Hospital Budapest, Budapest, Hungary; Yan Sun, Beijing Cancer Hospital, Beijing, China; Stefan Dietzsch, Hospital and Policlinic for Radiation Therapy and Radio-oncology, Leipzig, Germany; Pavol Dubinsky, East Slovakia Cancer Institute, Kosice, Slovakia; Petra Holeckova, Institute of Radiation Oncology, Hospital Na Bulovce, and 1st Medical Faculty of Charles University, Prague, Czech Republic; Iman El-Hariry, Synta Pharmaceutical, Lexington, MA; Paul Wissel and Mayur Amonkar, Novartis Pharmaceuticals, East Hanover, NJ; Catherine Ellis and Sergio Santillana, GlaxoSmithKline, Philadelphia, PA; and Nigel Biswas-Baldwin, Philippe Legenne, Thelma Netherway, Jing Wang-Silvanto, and Nazma Ahmed, Novartis Pharma AG, Basel, Switzerland.
  • Franklin N Kevin Harrington, Institute of Cancer Research and Royal Marsden Hospital, London; Hisham Mehanna, Institute of Head and Neck Studies and Education, University of Birmingham, Birmingham; Natalie Franklin and John Farrell, GlaxoSmithKline, Uxbridge, United Kingdom; Stephane Temam and Jean Bourhis, Institut Gustave- Roussy, Villejuif; Ida D'Onofrio, Hôpital Forcilles, Paris, France; Anil D'Cruz, Tata Memorial Hospital, Mumbai; Minish Jain, Ruby Hall Clinic-Cancer Centre, Pune, India; Georgy Manikhas, St Petersburg City Oncology Dispensary, St Petersburg, Russia; Zsuzsanna Horvath, Szent Imre University Teaching Hospital Budapest, Budapest, Hungary; Yan Sun, Beijing Cancer Hospital, Beijing, China; Stefan Dietzsch, Hospital and Policlinic for Radiation Therapy and Radio-oncology, Leipzig, Germany; Pavol Dubinsky, East Slovakia Cancer Institute, Kosice, Slovakia; Petra Holeckova, Institute of Radiation Oncology, Hospital Na Bulovce, and 1st Medical Faculty of Charles University, Prague, Czech Republic; Iman El-Hariry, Synta Pharmaceutical, Lexington, MA; Paul Wissel and Mayur Amonkar, Novartis Pharmaceuticals, East Hanover, NJ; Catherine Ellis and Sergio Santillana, GlaxoSmithKline, Philadelphia, PA; and Nigel Biswas-Baldwin, Philippe Legenne, Thelma Netherway, Jing Wang-Silvanto, and Nazma Ahmed, Novartis Pharma AG, Basel, Switzerland.
  • Biswas-Baldwin N Kevin Harrington, Institute of Cancer Research and Royal Marsden Hospital, London; Hisham Mehanna, Institute of Head and Neck Studies and Education, University of Birmingham, Birmingham; Natalie Franklin and John Farrell, GlaxoSmithKline, Uxbridge, United Kingdom; Stephane Temam and Jean Bourhis, Institut Gustave- Roussy, Villejuif; Ida D'Onofrio, Hôpital Forcilles, Paris, France; Anil D'Cruz, Tata Memorial Hospital, Mumbai; Minish Jain, Ruby Hall Clinic-Cancer Centre, Pune, India; Georgy Manikhas, St Petersburg City Oncology Dispensary, St Petersburg, Russia; Zsuzsanna Horvath, Szent Imre University Teaching Hospital Budapest, Budapest, Hungary; Yan Sun, Beijing Cancer Hospital, Beijing, China; Stefan Dietzsch, Hospital and Policlinic for Radiation Therapy and Radio-oncology, Leipzig, Germany; Pavol Dubinsky, East Slovakia Cancer Institute, Kosice, Slovakia; Petra Holeckova, Institute of Radiation Oncology, Hospital Na Bulovce, and 1st Medical Faculty of Charles University, Prague, Czech Republic; Iman El-Hariry, Synta Pharmaceutical, Lexington, MA; Paul Wissel and Mayur Amonkar, Novartis Pharmaceuticals, East Hanover, NJ; Catherine Ellis and Sergio Santillana, GlaxoSmithKline, Philadelphia, PA; and Nigel Biswas-Baldwin, Philippe Legenne, Thelma Netherway, Jing Wang-Silvanto, and Nazma Ahmed, Novartis Pharma AG, Basel, Switzerland.
  • Legenne P Kevin Harrington, Institute of Cancer Research and Royal Marsden Hospital, London; Hisham Mehanna, Institute of Head and Neck Studies and Education, University of Birmingham, Birmingham; Natalie Franklin and John Farrell, GlaxoSmithKline, Uxbridge, United Kingdom; Stephane Temam and Jean Bourhis, Institut Gustave- Roussy, Villejuif; Ida D'Onofrio, Hôpital Forcilles, Paris, France; Anil D'Cruz, Tata Memorial Hospital, Mumbai; Minish Jain, Ruby Hall Clinic-Cancer Centre, Pune, India; Georgy Manikhas, St Petersburg City Oncology Dispensary, St Petersburg, Russia; Zsuzsanna Horvath, Szent Imre University Teaching Hospital Budapest, Budapest, Hungary; Yan Sun, Beijing Cancer Hospital, Beijing, China; Stefan Dietzsch, Hospital and Policlinic for Radiation Therapy and Radio-oncology, Leipzig, Germany; Pavol Dubinsky, East Slovakia Cancer Institute, Kosice, Slovakia; Petra Holeckova, Institute of Radiation Oncology, Hospital Na Bulovce, and 1st Medical Faculty of Charles University, Prague, Czech Republic; Iman El-Hariry, Synta Pharmaceutical, Lexington, MA; Paul Wissel and Mayur Amonkar, Novartis Pharmaceuticals, East Hanover, NJ; Catherine Ellis and Sergio Santillana, GlaxoSmithKline, Philadelphia, PA; and Nigel Biswas-Baldwin, Philippe Legenne, Thelma Netherway, Jing Wang-Silvanto, and Nazma Ahmed, Novartis Pharma AG, Basel, Switzerland.
  • Wissel P Kevin Harrington, Institute of Cancer Research and Royal Marsden Hospital, London; Hisham Mehanna, Institute of Head and Neck Studies and Education, University of Birmingham, Birmingham; Natalie Franklin and John Farrell, GlaxoSmithKline, Uxbridge, United Kingdom; Stephane Temam and Jean Bourhis, Institut Gustave- Roussy, Villejuif; Ida D'Onofrio, Hôpital Forcilles, Paris, France; Anil D'Cruz, Tata Memorial Hospital, Mumbai; Minish Jain, Ruby Hall Clinic-Cancer Centre, Pune, India; Georgy Manikhas, St Petersburg City Oncology Dispensary, St Petersburg, Russia; Zsuzsanna Horvath, Szent Imre University Teaching Hospital Budapest, Budapest, Hungary; Yan Sun, Beijing Cancer Hospital, Beijing, China; Stefan Dietzsch, Hospital and Policlinic for Radiation Therapy and Radio-oncology, Leipzig, Germany; Pavol Dubinsky, East Slovakia Cancer Institute, Kosice, Slovakia; Petra Holeckova, Institute of Radiation Oncology, Hospital Na Bulovce, and 1st Medical Faculty of Charles University, Prague, Czech Republic; Iman El-Hariry, Synta Pharmaceutical, Lexington, MA; Paul Wissel and Mayur Amonkar, Novartis Pharmaceuticals, East Hanover, NJ; Catherine Ellis and Sergio Santillana, GlaxoSmithKline, Philadelphia, PA; and Nigel Biswas-Baldwin, Philippe Legenne, Thelma Netherway, Jing Wang-Silvanto, and Nazma Ahmed, Novartis Pharma AG, Basel, Switzerland.
  • Netherway T Kevin Harrington, Institute of Cancer Research and Royal Marsden Hospital, London; Hisham Mehanna, Institute of Head and Neck Studies and Education, University of Birmingham, Birmingham; Natalie Franklin and John Farrell, GlaxoSmithKline, Uxbridge, United Kingdom; Stephane Temam and Jean Bourhis, Institut Gustave- Roussy, Villejuif; Ida D'Onofrio, Hôpital Forcilles, Paris, France; Anil D'Cruz, Tata Memorial Hospital, Mumbai; Minish Jain, Ruby Hall Clinic-Cancer Centre, Pune, India; Georgy Manikhas, St Petersburg City Oncology Dispensary, St Petersburg, Russia; Zsuzsanna Horvath, Szent Imre University Teaching Hospital Budapest, Budapest, Hungary; Yan Sun, Beijing Cancer Hospital, Beijing, China; Stefan Dietzsch, Hospital and Policlinic for Radiation Therapy and Radio-oncology, Leipzig, Germany; Pavol Dubinsky, East Slovakia Cancer Institute, Kosice, Slovakia; Petra Holeckova, Institute of Radiation Oncology, Hospital Na Bulovce, and 1st Medical Faculty of Charles University, Prague, Czech Republic; Iman El-Hariry, Synta Pharmaceutical, Lexington, MA; Paul Wissel and Mayur Amonkar, Novartis Pharmaceuticals, East Hanover, NJ; Catherine Ellis and Sergio Santillana, GlaxoSmithKline, Philadelphia, PA; and Nigel Biswas-Baldwin, Philippe Legenne, Thelma Netherway, Jing Wang-Silvanto, and Nazma Ahmed, Novartis Pharma AG, Basel, Switzerland.
  • Farrell J Kevin Harrington, Institute of Cancer Research and Royal Marsden Hospital, London; Hisham Mehanna, Institute of Head and Neck Studies and Education, University of Birmingham, Birmingham; Natalie Franklin and John Farrell, GlaxoSmithKline, Uxbridge, United Kingdom; Stephane Temam and Jean Bourhis, Institut Gustave- Roussy, Villejuif; Ida D'Onofrio, Hôpital Forcilles, Paris, France; Anil D'Cruz, Tata Memorial Hospital, Mumbai; Minish Jain, Ruby Hall Clinic-Cancer Centre, Pune, India; Georgy Manikhas, St Petersburg City Oncology Dispensary, St Petersburg, Russia; Zsuzsanna Horvath, Szent Imre University Teaching Hospital Budapest, Budapest, Hungary; Yan Sun, Beijing Cancer Hospital, Beijing, China; Stefan Dietzsch, Hospital and Policlinic for Radiation Therapy and Radio-oncology, Leipzig, Germany; Pavol Dubinsky, East Slovakia Cancer Institute, Kosice, Slovakia; Petra Holeckova, Institute of Radiation Oncology, Hospital Na Bulovce, and 1st Medical Faculty of Charles University, Prague, Czech Republic; Iman El-Hariry, Synta Pharmaceutical, Lexington, MA; Paul Wissel and Mayur Amonkar, Novartis Pharmaceuticals, East Hanover, NJ; Catherine Ellis and Sergio Santillana, GlaxoSmithKline, Philadelphia, PA; and Nigel Biswas-Baldwin, Philippe Legenne, Thelma Netherway, Jing Wang-Silvanto, and Nazma Ahmed, Novartis Pharma AG, Basel, Switzerland.
  • Ellis C Kevin Harrington, Institute of Cancer Research and Royal Marsden Hospital, London; Hisham Mehanna, Institute of Head and Neck Studies and Education, University of Birmingham, Birmingham; Natalie Franklin and John Farrell, GlaxoSmithKline, Uxbridge, United Kingdom; Stephane Temam and Jean Bourhis, Institut Gustave- Roussy, Villejuif; Ida D'Onofrio, Hôpital Forcilles, Paris, France; Anil D'Cruz, Tata Memorial Hospital, Mumbai; Minish Jain, Ruby Hall Clinic-Cancer Centre, Pune, India; Georgy Manikhas, St Petersburg City Oncology Dispensary, St Petersburg, Russia; Zsuzsanna Horvath, Szent Imre University Teaching Hospital Budapest, Budapest, Hungary; Yan Sun, Beijing Cancer Hospital, Beijing, China; Stefan Dietzsch, Hospital and Policlinic for Radiation Therapy and Radio-oncology, Leipzig, Germany; Pavol Dubinsky, East Slovakia Cancer Institute, Kosice, Slovakia; Petra Holeckova, Institute of Radiation Oncology, Hospital Na Bulovce, and 1st Medical Faculty of Charles University, Prague, Czech Republic; Iman El-Hariry, Synta Pharmaceutical, Lexington, MA; Paul Wissel and Mayur Amonkar, Novartis Pharmaceuticals, East Hanover, NJ; Catherine Ellis and Sergio Santillana, GlaxoSmithKline, Philadelphia, PA; and Nigel Biswas-Baldwin, Philippe Legenne, Thelma Netherway, Jing Wang-Silvanto, and Nazma Ahmed, Novartis Pharma AG, Basel, Switzerland.
  • Wang-Silvanto J Kevin Harrington, Institute of Cancer Research and Royal Marsden Hospital, London; Hisham Mehanna, Institute of Head and Neck Studies and Education, University of Birmingham, Birmingham; Natalie Franklin and John Farrell, GlaxoSmithKline, Uxbridge, United Kingdom; Stephane Temam and Jean Bourhis, Institut Gustave- Roussy, Villejuif; Ida D'Onofrio, Hôpital Forcilles, Paris, France; Anil D'Cruz, Tata Memorial Hospital, Mumbai; Minish Jain, Ruby Hall Clinic-Cancer Centre, Pune, India; Georgy Manikhas, St Petersburg City Oncology Dispensary, St Petersburg, Russia; Zsuzsanna Horvath, Szent Imre University Teaching Hospital Budapest, Budapest, Hungary; Yan Sun, Beijing Cancer Hospital, Beijing, China; Stefan Dietzsch, Hospital and Policlinic for Radiation Therapy and Radio-oncology, Leipzig, Germany; Pavol Dubinsky, East Slovakia Cancer Institute, Kosice, Slovakia; Petra Holeckova, Institute of Radiation Oncology, Hospital Na Bulovce, and 1st Medical Faculty of Charles University, Prague, Czech Republic; Iman El-Hariry, Synta Pharmaceutical, Lexington, MA; Paul Wissel and Mayur Amonkar, Novartis Pharmaceuticals, East Hanover, NJ; Catherine Ellis and Sergio Santillana, GlaxoSmithKline, Philadelphia, PA; and Nigel Biswas-Baldwin, Philippe Legenne, Thelma Netherway, Jing Wang-Silvanto, and Nazma Ahmed, Novartis Pharma AG, Basel, Switzerland.
  • Amonkar M Kevin Harrington, Institute of Cancer Research and Royal Marsden Hospital, London; Hisham Mehanna, Institute of Head and Neck Studies and Education, University of Birmingham, Birmingham; Natalie Franklin and John Farrell, GlaxoSmithKline, Uxbridge, United Kingdom; Stephane Temam and Jean Bourhis, Institut Gustave- Roussy, Villejuif; Ida D'Onofrio, Hôpital Forcilles, Paris, France; Anil D'Cruz, Tata Memorial Hospital, Mumbai; Minish Jain, Ruby Hall Clinic-Cancer Centre, Pune, India; Georgy Manikhas, St Petersburg City Oncology Dispensary, St Petersburg, Russia; Zsuzsanna Horvath, Szent Imre University Teaching Hospital Budapest, Budapest, Hungary; Yan Sun, Beijing Cancer Hospital, Beijing, China; Stefan Dietzsch, Hospital and Policlinic for Radiation Therapy and Radio-oncology, Leipzig, Germany; Pavol Dubinsky, East Slovakia Cancer Institute, Kosice, Slovakia; Petra Holeckova, Institute of Radiation Oncology, Hospital Na Bulovce, and 1st Medical Faculty of Charles University, Prague, Czech Republic; Iman El-Hariry, Synta Pharmaceutical, Lexington, MA; Paul Wissel and Mayur Amonkar, Novartis Pharmaceuticals, East Hanover, NJ; Catherine Ellis and Sergio Santillana, GlaxoSmithKline, Philadelphia, PA; and Nigel Biswas-Baldwin, Philippe Legenne, Thelma Netherway, Jing Wang-Silvanto, and Nazma Ahmed, Novartis Pharma AG, Basel, Switzerland.
  • Ahmed N Kevin Harrington, Institute of Cancer Research and Royal Marsden Hospital, London; Hisham Mehanna, Institute of Head and Neck Studies and Education, University of Birmingham, Birmingham; Natalie Franklin and John Farrell, GlaxoSmithKline, Uxbridge, United Kingdom; Stephane Temam and Jean Bourhis, Institut Gustave- Roussy, Villejuif; Ida D'Onofrio, Hôpital Forcilles, Paris, France; Anil D'Cruz, Tata Memorial Hospital, Mumbai; Minish Jain, Ruby Hall Clinic-Cancer Centre, Pune, India; Georgy Manikhas, St Petersburg City Oncology Dispensary, St Petersburg, Russia; Zsuzsanna Horvath, Szent Imre University Teaching Hospital Budapest, Budapest, Hungary; Yan Sun, Beijing Cancer Hospital, Beijing, China; Stefan Dietzsch, Hospital and Policlinic for Radiation Therapy and Radio-oncology, Leipzig, Germany; Pavol Dubinsky, East Slovakia Cancer Institute, Kosice, Slovakia; Petra Holeckova, Institute of Radiation Oncology, Hospital Na Bulovce, and 1st Medical Faculty of Charles University, Prague, Czech Republic; Iman El-Hariry, Synta Pharmaceutical, Lexington, MA; Paul Wissel and Mayur Amonkar, Novartis Pharmaceuticals, East Hanover, NJ; Catherine Ellis and Sergio Santillana, GlaxoSmithKline, Philadelphia, PA; and Nigel Biswas-Baldwin, Philippe Legenne, Thelma Netherway, Jing Wang-Silvanto, and Nazma Ahmed, Novartis Pharma AG, Basel, Switzerland.
  • Santillana S Kevin Harrington, Institute of Cancer Research and Royal Marsden Hospital, London; Hisham Mehanna, Institute of Head and Neck Studies and Education, University of Birmingham, Birmingham; Natalie Franklin and John Farrell, GlaxoSmithKline, Uxbridge, United Kingdom; Stephane Temam and Jean Bourhis, Institut Gustave- Roussy, Villejuif; Ida D'Onofrio, Hôpital Forcilles, Paris, France; Anil D'Cruz, Tata Memorial Hospital, Mumbai; Minish Jain, Ruby Hall Clinic-Cancer Centre, Pune, India; Georgy Manikhas, St Petersburg City Oncology Dispensary, St Petersburg, Russia; Zsuzsanna Horvath, Szent Imre University Teaching Hospital Budapest, Budapest, Hungary; Yan Sun, Beijing Cancer Hospital, Beijing, China; Stefan Dietzsch, Hospital and Policlinic for Radiation Therapy and Radio-oncology, Leipzig, Germany; Pavol Dubinsky, East Slovakia Cancer Institute, Kosice, Slovakia; Petra Holeckova, Institute of Radiation Oncology, Hospital Na Bulovce, and 1st Medical Faculty of Charles University, Prague, Czech Republic; Iman El-Hariry, Synta Pharmaceutical, Lexington, MA; Paul Wissel and Mayur Amonkar, Novartis Pharmaceuticals, East Hanover, NJ; Catherine Ellis and Sergio Santillana, GlaxoSmithKline, Philadelphia, PA; and Nigel Biswas-Baldwin, Philippe Legenne, Thelma Netherway, Jing Wang-Silvanto, and Nazma Ahmed, Novartis Pharma AG, Basel, Switzerland.
  • Bourhis J Kevin Harrington, Institute of Cancer Research and Royal Marsden Hospital, London; Hisham Mehanna, Institute of Head and Neck Studies and Education, University of Birmingham, Birmingham; Natalie Franklin and John Farrell, GlaxoSmithKline, Uxbridge, United Kingdom; Stephane Temam and Jean Bourhis, Institut Gustave- Roussy, Villejuif; Ida D'Onofrio, Hôpital Forcilles, Paris, France; Anil D'Cruz, Tata Memorial Hospital, Mumbai; Minish Jain, Ruby Hall Clinic-Cancer Centre, Pune, India; Georgy Manikhas, St Petersburg City Oncology Dispensary, St Petersburg, Russia; Zsuzsanna Horvath, Szent Imre University Teaching Hospital Budapest, Budapest, Hungary; Yan Sun, Beijing Cancer Hospital, Beijing, China; Stefan Dietzsch, Hospital and Policlinic for Radiation Therapy and Radio-oncology, Leipzig, Germany; Pavol Dubinsky, East Slovakia Cancer Institute, Kosice, Slovakia; Petra Holeckova, Institute of Radiation Oncology, Hospital Na Bulovce, and 1st Medical Faculty of Charles University, Prague, Czech Republic; Iman El-Hariry, Synta Pharmaceutical, Lexington, MA; Paul Wissel and Mayur Amonkar, Novartis Pharmaceuticals, East Hanover, NJ; Catherine Ellis and Sergio Santillana, GlaxoSmithKline, Philadelphia, PA; and Nigel Biswas-Baldwin, Philippe Legenne, Thelma Netherway, Jing Wang-Silvanto, and Nazma Ahmed, Novartis Pharma AG, Basel, Switzerland. jean.bourhis@chuv.ch.
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  • 2015-11-04
Published in:
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology. - 2015
Adult
Aged
Antineoplastic Combined Chemotherapy Protocols
Carcinoma, Squamous Cell
Cetuximab
Chemoradiotherapy
Chemotherapy, Adjuvant
Cisplatin
Disease-Free Survival
Dose Fractionation, Radiation
Double-Blind Method
ErbB Receptors
Female
Head and Neck Neoplasms
Humans
International Cooperation
Kaplan-Meier Estimate
Lapatinib
Maintenance Chemotherapy
Male
Middle Aged
Molecular Targeted Therapy
Odds Ratio
Quinazolines
Squamous Cell Carcinoma of Head and Neck
Treatment Outcome
English PURPOSE
This multicenter phase III study evaluated the efficacy and safety of lapatinib, an epidermal growth factor receptor/ErbB2 inhibitor, administered concomitantly with chemoradiotherapy and as maintenance monotherapy in patients with high-risk surgically treated squamous cell carcinoma of the head and neck (SCCHN).


PATIENTS AND METHODS
Patients with resected stage II to IVA SCCHN, with a surgical margin ≤ 5 mm and/or extracapsular extension, were randomly assigned to chemoradiotherapy (66 Gy total radiation dose and cisplatin 100 mg/m(2) per day administered on days 1, 22, and 43) plus placebo or lapatinib (1,500 mg per day) before and during chemoradiotherapy, followed by 12 months of maintenance monotherapy.


RESULTS
Six hundred eighty-eight patients were enrolled (lapatinib, n = 346; placebo, n = 342). With a median follow-up time of 35.3 months, the study ended early because of the apparent plateauing of disease-free survival (DFS) events. Median DFS assessed by an independent review committee was 53.6 months and not reached for lapatinib and placebo, respectively (hazard ratio, 1.10; 95% CI, 0.85 to 1.43). Investigator-assessed results confirmed the independent review committee assessment. No significant differences in DFS by human papillomavirus status or overall survival were observed between treatment arms. Similar numbers of patients in both treatment arms experienced adverse events (AEs), with more patients in the lapatinib arm than the placebo arm experiencing serious AEs (48% v 40%, respectively). The most commonly observed treatment-related AEs were diarrhea and rash, both predominantly in the lapatinib arm.


CONCLUSION
Addition of lapatinib to chemoradiotherapy and its use as long-term maintenance therapy does not offer any efficacy benefits and had additional toxicity compared with placebo in patients with surgically treated high-risk SCCHN.
Language
  • English
Open access status
closed
Identifiers
Persistent URL
https://sonar.ch/global/documents/123020
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