Induction Chemotherapy Followed by ChemoRadiotherapy Increased Time-to-Treatment Failure Compared to ChemoRadiotherapy Alone in Patients With Unresectable Locally Advanced Head & Neck Cancer

MADRID - Phase 3 study has demonstrated that Induction Chemotherapy prior to ChemoRadiotherapy significantly increased time-to-treatment failure in comparison to standard ChemoRadiotherapy alone -

The Spanish Head and Neck Cancer Cooperative Group (TTCC) announced today that Induction Chemotherapy (IC) delivered prior to standard ChemoRadiotherapy (CRT), a treatment paradigm defined as sequential therapy, compared to upfront CRT alone, significantly prolonged Time-to-Treatment Failure (TTF) for patients with unresectable Locally Advanced Head and Neck Cancer (LAHNC). The endpoint of Time-to-Treatment Failure was defined as a composite of time-to-disease progression, -to-surgery or other cancer-related treatments, -to-drop-out due to an adverse event, and to death from any cause.

Final results (abstract #6009) from the Phase 3 randomized study were presented by Prof. Ricardo Hitt, of the University Hospital 12 de Octubre, Madrid, in an oral presentation at the 2009 annual meeting of the American Society of Clinical Oncology (ASCO). The results of this study have also been selected for inclusion in the Best of ASCO(R) program. The Best of ASCO(R) is an educational initiative that condenses highlights from ASCO’s Annual Meeting, with the objective of increasing global access to cutting-edge science that is relevant and significant in oncology today.

This study enrolled 439 patients with Locally Advanced Head and Neck Cancer with good performance status, who were randomly assigned to receive standard CRT (cisplatin and fractionated radiation) versus the same treatment preceded by IC, which consisted of cisplatin plus 5-fluorouracil (5-FU) with or without Taxotere(R) (docetaxel) Injection Concentrate. The study was designed to compare the results of those patients who received IC prior to CRT (sequential therapy) and patients who received CRT alone.

The sequential therapy of adding IC to CRT improved Time-to-Treatment Failure (TTF) from 5.0 months to 12.5 months (p< 0.0001), a 7.5 month increase. Furthermore, a secondary endpoint of loco-regional control, was observed in 61.5% of the patients treated with the sequential strategy (IC+CRT) compared to 44.5% of those patients treated with CRT alone (p=0.002).

The most frequent severe (grade 3-4) adverse reactions were stomatitis (44% for IC+CRT vs. 31% for CRT) and febrile neutropenia (10% for IC+CRT vs. 1% for CRT). Other adverse events included neutropenia and asthenia.

“These study results illustrate that this complex disease deserves a rational and comprehensive management strategy to overcome its pathologic mechanism and the inherent possibility of failure of clinical control,” said Prof. Ricardo Hitt, MD, PhD, the study principal investigator, from Medical Oncology Service of the University Hospital 12 de Octubre, Madrid, Spain.

Every year more than 640,000 people worldwide are diagnosed with head and neck cancer, and an estimated more than 350,000 will die from the disease. Head and neck cancer is a group of tumors that mostly arise in the cells that line the mucosal surfaces, giving rise to squamous cell carcinoma in the head and neck area, such as the mouth, tongue, tonsils, voice box and throat.

“This trial showed that adding Induction Chemotherapy to ChemoRadiotherapy increased failure-free survival while significantly increasing local control in patients with advanced unresectable head and neck cancer,” said Fadlo Khuri, MD, Professor and Roberto Goizueta Chair of Hematology and Medical Oncology at Emory University, Atlanta, GA, USA. Dr. Khuri, a renowned head and neck cancer expert, also added: “These data may help define and clarify standard approaches to the treatment of patients with advanced unresectable disease.”

About the Spanish Head and Neck Cancer Cooperative Group, TTCC

Grupo Espanol de Tratamiento de Tumores de Cabeza y Cuello (TTCC) is a Spanish non-profit scientific cooperative group fully devoted to head and neck cancer. The group is comprised of medical oncologists, who belong to the Spanish Society of Medical Oncology (SEOM) as well as of other health professionals related to head and neck cancer research and treatment. The main Spanish Head and Neck Cancer Cooperative Group objectives are to promote basic, epidemiological and clinical research, and to provide education to doctors and patients and dissemination of information in the field of head and neck cancer to the Spanish general population.

Contact TTCC: Pr. Ricardo Hitt: +34-629-26-28-33 Tara Dimilia: +1-908-884-7024

Source: Spanish Head and Neck Cancer Cooperative Group

Professor Ricardo Hitt, +34-629-26-28-33, or Tara Dimilia, +1-908-884-7024, both for Spanish Head and Neck Cancer Cooperative Group