Originally published as JCO Early Release 10.1200/JCO.2008.19.0256 on May 4 2009

This Article Full Text Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Google Scholar Articles by Siefker-Radtke, A. O. Articles by Millikan, R. E. PubMed PubMed Citation Articles by Siefker-Radtke, A. O. Articles by Millikan, R. E. Related Articles Related Article Related Editorial Social Bookmarking                            What's this?

Phase II Clinical Trial of Neoadjuvant Alternating Doublet Chemotherapy With Ifosfamide/Doxorubicin and Etoposide/Cisplatin in Small-Cell Urothelial Cancer

From the Departments of Genitourinary Medical Oncology, Urology, and Biostatistics, The University of Texas M. D. Anderson Cancer Center, Houston, TX.

Corresponding author: Arlene Siefker-Radtke, MD, The University of Texas M. D. Anderson Cancer Center, Department of Genitourinary Medical Oncology, 1515 Holcombe Blvd, Unit 1374, Houston, TX 77030; e-mail: asiefker{at}mdanderson.org.

Purpose Currently, treatment recommendations for small-cell urothelial cancer (SCUC) are based on anecdotal case reports and small retrospective series. We now report results from the first phase II clinical trial developed exclusively for SCUC, to our knowledge.

Patients and Methods From 2001 to 2006, 30 patients with SCUC provided consent and were treated with alternating doublet chemotherapy. Patients with surgically resectable disease ( cT4aN0M0) received a total of four cycles of neoadjuvant chemotherapy, whereas those with unresectable disease ( cT4b, N+, or M+) received two cycles beyond maximal response.

Results Eighteen patients with surgically resectable SCUC received neoadjuvant treatment with a median overall survival (OS) of 58 months; 13 of these patients remain alive and cancer free. For patients with cT2N0M0 SCUC, the 5-year OS rate is 80%; only one of four patients with cT3b-4aN0M0 remains alive (median OS, 37.8 months). For 12 patients with unresectable or metastatic SCUC, the median OS was 13.3 months. Chemotherapy was well tolerated, with transfusion, neutropenic fever, and infection remaining the most frequent grade 3 and 4 toxicities. There was only one postsurgical death. Brain metastases were strongly associated with more advanced-stage disease, developing in eight of 16 patients with either bulky tumors ( cT3b) or metastatic disease (P = .004).

Conclusion These clinical trial results are consistent with previously reported retrospective data demonstrating long-term survival with four cycles of neoadjuvant chemotherapy for surgically resectable SCUC. Once metastases develop, the prognosis remains poor. The strong positive association between disease stage and brain metastases highlights a patient subset that may potentially benefit from prophylactic cranial irradiation.

Presented in part at the 43rd Annual Meeting of the American Society of Clinical Oncology, June 1-5, 2007, Chicago, IL.

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

CiteULike    Complore    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?

Related Article

• Phase II Study of Capecitabine and Oxaliplatin for Advanced Adenocarcinoma of the Small Bowel and Ampulla of Vater
  Michael J. Overman, Gauri R. Varadhachary, Scott Kopetz, Rosni Adinin, E. Lin, Jeffrey S. Morris, Cathy Eng, James L. Abbruzzese, and Robert A. Wolff
  JCO 2009 27: 2598-2603 [Abstract] [Full Text]

Related Editorial

• To Make Progress in Rare Cancers, Patients Must Lead the Way
  Amy Dockser Marcus
  JCO 2009 27: 2575-2577 [Full Text]