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Combined chemotherapy and radiation therapy in advanced inoperable squamous cell carcinoma of the head and neck. The final report of a randomized trial

1991; Wiley; Volume: 67; Issue: 4 Linguagem: Inglês

10.1002/1097-0142(19910215)67

1097-0142

Marco Merlano, Renzo Corvò, G Margarino, Marco Benasso, R. Rosso, M. R. Sertoli, M. Cavallari, Marco Scala, M. Guenzi, L. Santi, A Siragusa, Fulvio Brema, G. Luzi, G Bottero, Giovanni Biondi, Felice Scasso, G Garaventa, E Accomando, Alida Santelli, Gabriela Cordone, S. Vitriolo, G. Comella,

Salivary Gland Tumors Diagnosis and Treatment

CancerVolume 67, Issue 4 p. 915-921 Clinical TrialFree Access Combined chemotherapy and radiation therapy in advanced inoperable squamous cell carcinoma of the head and neck. The final report of a randomized trial M. Merlano MD, Corresponding Author M. Merlano MD Istituto Nazionale per la Ricerca sul Cancro, GenevaIstituto Nazionale per la Ricerca sul Cancro, Viale Benedetto XV, 10, 16132 Genova, Italy===Search for more papers by this authorR. Corvo' MD, R. Corvo' MD Istituto Nazionale per la Ricerca sul Cancro, Geneva Ospedale Galliera, GenovaSearch for more papers by this authorG. Margarino MD, G. Margarino MD Istituto Nazionale per la Ricerca sul Cancro, GenevaSearch for more papers by this authorM. Benasso MD, M. Benasso MD Istituto Nazionale per la Ricerca sul Cancro, GenevaSearch for more papers by this authorR. Rosso MD, R. Rosso MD Istituto Nazionale per la Ricerca sul Cancro, GenevaSearch for more papers by this authorM. R. Sertoli MD, M. R. Sertoli MD Istituto Nazionale per la Ricerca sul Cancro, GenevaSearch for more papers by this authorM. Cavallari MD, M. Cavallari MD Istituto Nazionale per la Ricerca sul Cancro, GenevaSearch for more papers by this authorM. Scala MD, M. Scala MD Istituto Nazionale per la Ricerca sul Cancro, GenevaSearch for more papers by this authorM. Guenzi MD, M. Guenzi MD Istituto Nazionale per la Ricerca sul Cancro, GenevaSearch for more papers by this authorL. Santi MD, L. Santi MD Istituto Nazionale per la Ricerca sul Cancro, GenevaSearch for more papers by this authorA. Siragusa MD, A. Siragusa MD Ospedale Galliera, GenovaSearch for more papers by this authorF. Brema MD, F. Brema MD Ospedale Civile, SavonaSearch for more papers by this authorG. Luzi MD, G. Luzi MD Ospedale Civile, SavonaSearch for more papers by this authorG. Bottero MD, G. Bottero MD Ospedale Civile, AlessandriaSearch for more papers by this authorG. Biondi MD, G. Biondi MD Ospedale Civile Sestri Ponente, GenovaSearch for more papers by this authorF. Scasso MD, F. Scasso MD Ospedale Celesia, GenevaSearch for more papers by this authorG. Garaventa MD, G. Garaventa MD Ospedale S. Martino, GenovaSearch for more papers by this authorE. Accomando MD, E. Accomando MD Ospedale S. Martino, GenovaSearch for more papers by this authorA. Santelli MD, A. Santelli MD Ospedale S. Martino, GenovaSearch for more papers by this authorG. Cordone MD, G. Cordone MD Ospedale S. Martino, GenovaSearch for more papers by this authorS. Vitriolo MD, S. Vitriolo MD Ospedale S. Martino, GenovaSearch for more papers by this authorG. Comella MD, G. Comella MD Istituto Tumori, Napoli, ItalySearch for more papers by this author M. Merlano MD, Corresponding Author M. Merlano MD Istituto Nazionale per la Ricerca sul Cancro, GenevaIstituto Nazionale per la Ricerca sul Cancro, Viale Benedetto XV, 10, 16132 Genova, Italy===Search for more papers by this authorR. Corvo' MD, R. Corvo' MD Istituto Nazionale per la Ricerca sul Cancro, Geneva Ospedale Galliera, GenovaSearch for more papers by this authorG. Margarino MD, G. Margarino MD Istituto Nazionale per la Ricerca sul Cancro, GenevaSearch for more papers by this authorM. Benasso MD, M. Benasso MD Istituto Nazionale per la Ricerca sul Cancro, GenevaSearch for more papers by this authorR. Rosso MD, R. Rosso MD Istituto Nazionale per la Ricerca sul Cancro, GenevaSearch for more papers by this authorM. R. Sertoli MD, M. R. Sertoli MD Istituto Nazionale per la Ricerca sul Cancro, GenevaSearch for more papers by this authorM. Cavallari MD, M. Cavallari MD Istituto Nazionale per la Ricerca sul Cancro, GenevaSearch for more papers by this authorM. Scala MD, M. Scala MD Istituto Nazionale per la Ricerca sul Cancro, GenevaSearch for more papers by this authorM. Guenzi MD, M. Guenzi MD Istituto Nazionale per la Ricerca sul Cancro, GenevaSearch for more papers by this authorL. Santi MD, L. Santi MD Istituto Nazionale per la Ricerca sul Cancro, GenevaSearch for more papers by this authorA. Siragusa MD, A. Siragusa MD Ospedale Galliera, GenovaSearch for more papers by this authorF. Brema MD, F. Brema MD Ospedale Civile, SavonaSearch for more papers by this authorG. Luzi MD, G. Luzi MD Ospedale Civile, SavonaSearch for more papers by this authorG. Bottero MD, G. Bottero MD Ospedale Civile, AlessandriaSearch for more papers by this authorG. Biondi MD, G. Biondi MD Ospedale Civile Sestri Ponente, GenovaSearch for more papers by this authorF. Scasso MD, F. Scasso MD Ospedale Celesia, GenevaSearch for more papers by this authorG. Garaventa MD, G. Garaventa MD Ospedale S. Martino, GenovaSearch for more papers by this authorE. Accomando MD, E. Accomando MD Ospedale S. Martino, GenovaSearch for more papers by this authorA. Santelli MD, A. Santelli MD Ospedale S. Martino, GenovaSearch for more papers by this authorG. Cordone MD, G. Cordone MD Ospedale S. Martino, GenovaSearch for more papers by this authorS. Vitriolo MD, S. Vitriolo MD Ospedale S. Martino, GenovaSearch for more papers by this authorG. Comella MD, G. Comella MD Istituto Tumori, Napoli, ItalySearch for more papers by this author First published: 15 February 1991 https://doi.org/10.1002/1097-0142(19910215)67:4 3.0.CO;2-8Citations: 76AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Abstract Between 1983 and 1986, the National Institute for Cancer Research in Genoa and affiliated institutions conducted a randomized study to compare two different ways of combining chemotherapy (CT) and radiation therapy (RT). One hundred sixteen patients were randomized to receive neoadjuvant CT followed by definitive RT (treatment arm A) or alternating CT and RT. In treatment arm A, RT consisted of 70 Gy to the involved areas and 50 Gy to the uninvolved neck at 2 Gy/fraction, five fractions per week. In treatment arm B, RT consisted of 60 Gy to involved areas and 50 Gy to the uninvolved neck in three courses of 20 Gy each, 2 Gy/fraction, ten fractions/2 weeks alternated with four courses of CT. CT consisted of vinblastine 6 mg/m2 intravenously followed 6 hours later by bleomycin 30 IU intramuscularly, day 1; methotrexate 200 mg intravenously, day 2; leucovorin rescue, day 3. CT was repeated every 2 weeks up to four courses. The same CT was used in both treatment arms of the study. Fifty-five patients were entered in treatment arm A and 61 in treatment arm B. Complete responses were 7/48 and 19/57 in treatment arms A and B, respectively (P < 0.03). Four-year progression-free survival was 4% in treatment arm A and 12% in treatment arm B (P < 0.02), and four-year survival was 10% in A and 22% in B (P < 0.02). Mucosal tolerance was significantly worse in treatment arm B (P < 0.00004). The subgroup analysis shows the major improvement of alternating CT and RT in patients with the worst prognostic characteristics. References 1 Fazekas JT, Sommer C, Kramer S. Adjuvant intravenous methotrexate or definitive radiotherapy alone for advanced squamous cancers of the oral cavity, oropharynx, supraglottic larynx or hypopharynx. Int J Radiat Oncol Biol Phys 1980; 6: 533– 541. 2 Head and Neck Contracts Program. Adjuvant chemotherapy for advanced head and neck squamous carcinoma. 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