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Phase II Study of Low-Dose Paclitaxel and Cisplatin in Combination With Split-Course Concomitant Twice-Daily Reirradiation in Recurrent Squamous Cell Carcinoma of the Head and Neck: Results of Radiation Therapy Oncology Group Protocol 9911

Corey J. Langer, Jonathan Harris, Eric M. Horwitz, Nicos Nicolaou, Merrill Kies, Walter Curran, Stuart Wong, Kian Ang

From the Fox Chase Cancer Center; Radiation Therapy Oncology Group Department of Statistics; Thomas Jefferson University Hospital, Philadelphia, PA; The University of Texas M.D. Anderson Cancer Center, Houston, TX; and the Medical College of Wisconsin, Milwaukee, WI

Address reprint requests to Corey J. Langer, MD, Fox Chase Cancer Center, 333 Cottman Ave, Philadelphia, PA 19111; e-mail: cj_langer{at}fccc.edu

Purpose: Recurrent squamous cell carcinoma of the head and neck (SCCHN) or new second primary tumor (SPT) in a previous radiation field, if not curable by surgery or radiation, is almost always fatal. Chemotherapy alone yields a median survival time (MST) of no more than 10 months and 1-year overall survival (OS) of 35% at best. Concurrent reirradiation and chemotherapy is an alternative strategy.

Patients and Methods: Eligibility for Radiation Therapy Oncology Group (RTOG) protocol 9911 stipulated recurrent SCCHN or SPT in a previous radiation field. Patients received twice-daily radiation (1.5 Gy per fraction bid x 5 days every 2 weeks x4), plus cisplatin 15 mg/m² intravenously (IV) daily x 5 and paclitaxel 20 mg/m² IV daily x 5 every 2 weeks x4. Granulocyte colony-stimulated factor was administered days 6 through 13 of each 2-week cycle.

Results: One hundred five patients were enrolled from March 2000 through June 2003; 23% had SPT. Oropharynx (40%) and oral cavity (27%) were the predominant primary sites. Median prior radiation dose was 65.4 Gy. Seventy-four percent of patients completed chemotherapy. Grade 4 or worse acute toxicity occurred in 28%, grade 4 or worse acute hematologic toxicity in 21%. Eight treatment-related deaths (8%) occurred: five in the acute setting, three late (including two carotid hemorrhages). MST was 12.1 months, with estimated 1- and 2-year OS rates of 50.2% and 25.9%.

Conclusion: Despite a high incidence of grade 5 toxicity, 1- and 2-year OS rates for split-course bid radiation therapy and concurrent cisplatin/paclitaxel exceed results generally seen with chemotherapy alone.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.