Combined radiotherapy and chemotherapy in the treatment of squamous cell carcinoma of the head and neck: Results from two randomized trials

Aims and background Several strategies combining radiotherapy and chemotherapy have been developed for the cure of squamous cell carcinoma of the head and neck (SCC-HN) in an attempt to improve loco-regional control and survival. This overview aims to summarize clinical results of reported randomized trials and to discuss the biological mechanisms underlying the interactive and non-interactive processes promoted when chemotherapy is added to radiotherapy. Methods The clinical goals of combined modality therapy and exploitable associations of chemotherapy and radiotherapy that may lead to a therapeutic gain in comparison with radiotherapy alone are reported and reviewed. Clinical applications of the four main ways of combining chemotherapy with radiotherapy (neoadjuvant, concomitant, alternating and adjuvant) are briefly re-analyzed and discussed. Results and Conclusions Published evidence suggests that induction chemotherapy (neo-adjuvant) should not be routinely recommended; however, induction chemotherapy increases the likelihood of larynx preservation in patients with laryngeal and hypopharyngeal cancer and should be offered as a treatment option as an alternative to surgery. Positive results of several randomized studies and a recent meta-analysis show that concomitant use of chemotherapy and radiotherapy in unresectable SCCHN is beneficial and should be considered as a potential standard treatment. A complementary biological staging of SCCHN, by evaluating new predictive factors of tumor response, is presently under investigation to better interpretate clinical randomized trials exploring chemo-radiotherapy.

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Chemotherapy as an adjunct to radiation in the treatment of squamous cell carcinoma of the head and neck: results of the Yale Mitomycin Randomized Trials.

Journal of Clinical Oncology ◽

10.1200/jco.1997.15.1.268 ◽

1997 ◽

Vol 15 (1) ◽

pp. 268-276 ◽

Cited By ~ 106

Author(s):

B G Haffty ◽

Y H Son ◽

R Papac ◽

C T Sasaki ◽

J B Weissberg ◽

...

Keyword(s):

Squamous Cell Carcinoma ◽

Radiation Therapy ◽

Cell Carcinoma ◽

Head And Neck ◽

Squamous Cell ◽

Alkylating Agent ◽

Randomized Trials ◽

Free Survival ◽

Extent Of Disease ◽

Cause Specific Survival

PURPOSE Two consecutive randomized trials were run at our institution using the bioreductive alkylating agent mitomycin as an adjunct to radiation therapy in an effort to improve outcome in patients with squamous cell carcinoma of the head and neck. METHODS Between 1980 and 1992, two consecutive randomized trials using mitomycin (trial 1) and mitomycin with dicumarol (trial 2) as an adjunct to radiation therapy in patients with squamous cell carcinoma of the head and neck were conducted at our institution. The patients were stratified by intent of therapy, extent of disease, and primary tumor site. Within each strata, patients were randomized to receive radiation therapy with or without mitomycin (trial 1) or mitomycin/dicumarol (trial 2). RESULTS A total of 203 patients were enrolled onto both trials, 195 of whom were eligible for analysis. Patients were equally balanced with respect to sex, age, extent of disease, primary site, radiation dose, and total duration of radiation treatment. Hematologic toxicities were more frequently noted in the drug-treated arms, but were acceptable with no drug-related treatment deaths. Nonhematologic toxicities were acceptable and not significantly different between the two arms. As of September 1995, with a median follow-up of 138 months, a statistically significant benefit occurred in the mitomycin arms with respect to cause-specific survival (0.74 +/- 0.05 v 0.51 +/- 0.05; P = .005), local recurrence-free survival (0.85 +/- 0.04 v 0.66 +/- 0.05; P = .002), and local regional recurrence-free survival (0.76 +/- 0.05 v 0.54 +/- 0.05; P = .003). No statistically significant difference in overall survival was obtained (0.48 +/- 0.05 mitomycin arms v 0.42 +/- 0.05 radiation alone). CONCLUSION The bioreductive alkylating agent mitomycin is a safe and effective adjunct to radiation therapy in the treatment of squamous cell carcinoma of the head and neck. The statistically and clinically significant improvement in local regional relapse and cause-specific survival obtained support the use of mitomycin as an adjunct to radiation therapy in the management of squamous cell carcinoma of the head and neck.

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