Induction Chemotherapy Followed By Chemoradiotherapy Increased Time-to-treatment Failure Compared To

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31st May 2009, 12:01pm - Views: 848










Induction Chemotherapy Followed by ChemoRadiotherapy Increased Time-to-Treatment Failure

Compared to ChemoRadiotherapy Alone in Patients With Unresectable Locally Advanced Head &

Neck Cancer


PR34846


MADRID, May 30 /PRNewswire-AsiaNet/ --


     - 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:

Community Health Spanish Head And Neck Cancer Cooperative Group 2 image

"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: 908-884-7024


    SOURCE:  Spanish Head and Neck Cancer Cooperative Group


   CONTACT:  Professor Ricardo Hitt,

             +34-629-26-28-33, or 


             Tara Dimilia, 

             +1-908-884-7024,


             both for Spanish Head and Neck Cancer Cooperative Group















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