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Phase II/III Study of Doxorubicin With Fluorouracil Compared With Streptozocin With Fluorouracil or Dacarbazine in the Treatment of Advanced Carcinoid Tumors: Eastern Cooperative Oncology Group Study E1281

From the University of Pennsylvania, Philadelphia, PA; Dana Farber Cancer Institute, Boston, MA; Creighton University, Omaha, NE

Address reprint requests to Weijing Sun, MD, 16 Penn Tower, 3400 Spruce St, Abramson Cancer Center of University of Pennsylvania, Philadelphia, PA 19104-4283; e-mail: weijing.sun{at}uphs.upenn.edu

PURPOSE: Optimal treatments for metastatic carcinoid tumor remain undefined, and the role of chemotherapy for symptomatic patients with progressive disease is uncertain.

PATIENTS AND METHODS: Two hundred forty-nine patients with advanced carcinoid tumors were randomized to either doxorubicin with fluorouracil (FU/DOX) or streptozocin with fluorouracil (FU/STZ). Patients crossed over to the dacarbazine (DTIC) treatment after disease progression following first-line treatment (either FU/DOX or FU/STZ), and 73 patients were assigned to one of these three treatments based on their previous treatment or on abnormal baseline cardiac or renal function.

RESULTS: In the randomized group, there was no difference between FU/DOX and FU/STZ in response rates (15.9% v 16%) and progression-free survival (4.5 v 5.3 months). FU/STZ (24.3 months) was superior to FU/DOX (15.7 months; P = .0267) in median survival. The response rate of crossover DTIC treatment was 8.2%, with a median survival of 11.9 months. Hematologic toxicities were the major treatment-related toxicities for both FU/DOX and FU/STZ, and mild to moderate renal toxicity was reported in 40 (34.8%) of 115 patients in the FU/STZ arm.

CONCLUSION: Response to all three treatment regimens were modest. FU/STZ improved survival compared with the doxorubicin-based regimen, suggesting that the combination should be considered to be an active regimen of therapy when chemotherapy is judged to be an option for selected patients with carcinoid tumors.

Supported in part by Public Health Service grants CA23318, CA66636, CA21115, CA15488, CA13650, and from the National Cancer Institute, National Institutes of Health, and the Department of Health and Human Services.

This articles’ contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.

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

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