Originally published as JCO Early Release 10.1200/JCO.2008.16.2339 on May 19 2008

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Induction Therapy for Poor-Prognosis Anal Canal Carcinoma: A Phase II Study of the Cancer and Leukemia Group B (CALGB 9281)

Neal J. Meropol, Donna Niedzwiecki, Brenda Shank, Thomas A. Colacchio, John Ellerton, Frank Valone, Susan Budinger, Jeannette M. Day, Judy Hopkins, Joel Tepper, Richard M. Goldberg, Robert J. Mayer

From the Fox Chase Cancer Center, Philadelphia, PA; Cancer and Leukemia Group B Statistical Center, Duke University Medical Center; and University of North Carolina at Chapel Hill, Durham; and Wake Forest University, Winston-Salem, NC; Doctors Medical Center, San Pablo, CA; Dartmouth-Hitchcock Medical Center, Lebanon, NH; Southern Nevada Cancer Research Foundation Community Clinical Oncology Program, Las Vegas, NV; and Dana Farber Cancer Institute, Boston, MA

Corresponding author: Neal J. Meropol, MD, Fox Chase Cancer Center, 333 Cottman Ave, Philadelphia, Pa 19111; e-mail: neal.meropol{at}fccc.edu

Purpose Although most patients with anal canal cancer are cured with sphincter-preserving, nonsurgical, combined-modality therapy, those with large tumors and lymph node involvement have a poor prognosis. To establish the safety and efficacy of induction chemotherapy with infusional fluorouracil (FU) plus cisplatin followed by FU plus mitomycin C with concurrent radiation in patients with poor-prognosis squamous cell cancers of the anal canal.

Methods Patients with previously untreated anal canal cancers with T3 or T4 tumors and/or extensive nodal involvement (bulky N2 or N3) received two 28-day cycles of induction treatment with infusional FU plus cisplatin followed by two 28-day cycles of FU plus mitomycin C with concurrent split-course radiation. A third cycle of FU and cisplatin with radiation boost was given to patients with persistent primary site disease or bulky N2 or N3 disease at presentation.

Results Forty-five assessable patients received protocol therapy. Treatment was generally well tolerated, and gastrointestinal and hematologic toxicities were the most common. Induction chemotherapy resulted in eight complete and 21 partial responses. After induction, combined-modality, and boost therapy, 37 (82%) of 45 assessable high-risk patients achieved a complete response. After 4 years of follow-up, 68% of patients are alive, 61% are disease-free, and 50% are colostomy- and disease-free.

Conclusion A combined-modality approach that includes induction treatment with FU and cisplatin followed by combined-modality therapy with FU, mitomycin C, and concurrent radiation results in long-term disease control in the majority of patients with poor-prognosis anal canal cancer.

published online ahead of print at www.jco.org on May 19, 2008.

Supported in part by the following grants from the National Cancer Institute to: the Cancer and Leukemia Group B (CALGB; CA31946); the CALGB Statistical Center (CA33601); Dartmouth-Hitchcock Medical Center (CA04326); Southern Nevada Cancer Research Foundation Community Clinical Oncology Program (CA35421); Wake Forest University (CA03927); University of North Carolina at Chapel Hill (CA47559); and Dana Farber Cancer Institute (CA32291).

Presented in part at the 35^th Annual Meeting of the American Society of Clinical Oncology, May, 15-18, 1999, Atlanta, GA, and at the NTH Second Gastrointestinal Cancers Symposium, January 27-29, 2005, Miami, FL.

The content of this manuscript is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute.

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

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