A phase II trial of radiation therapy and weekly cisplatin chemotherapy for the treatment of locally-advanced squamous cell carcinoma of the vulva: A gynecologic oncology group study
Highlights
► Preoperative radiation therapy plus weekly cisplatin chemotherapy is effective treatment for locally-advanced vulvar cancer. ► Among patients treated in this prospective phase II study, complete clinical and pathological responses occurred in 64% and 50%, respectively.
Section snippets
Objectives
The management of patients with locally advanced vulvar cancer presents a difficult therapeutic challenge. Historically, when the disease involves the anus, rectum, rectovaginal septum, proximal urethra, or bladder, primary exenterative surgery necessitating colostomy and/or urinary diversion has been required. Boronow [1] and Hacker [2] independently explored the efficacy of a radiation-surgical approach for advanced vulvar cancer as an alternative to pelvic exenteration. In Boronow's series,
Methods
The study was limited to patients with locally-advanced, previously untreated squamous cell carcinoma of the vulva with T3 or T4 primary tumors (N0-3, M0) [7] not amenable to surgical resection by standard radical vulvectomy. Patients had GOG Performance Status of 0–3, adequate bone marrow function, renal and hepatic function, and were judged capable of tolerating a radical course of chemoradiation therapy. Patients with vulvar melanomas or sarcomas, septicemia or severe infection,
Results
The study was opened to initial patient accrual 1/19/05. After the planned interim analysis indicated sufficient activity, the study was reopened to a second stage of accrual 7/16/07 and closed 9/21/09. There were 61 women entered into the study and three were later deemed ineligible: improper pre-protocol therapy (N = 1); inadequate pathology (N = 2). Characteristics of the 58 patients evaluable for response and toxicity are listed in Table 1. All study participants had previously untreated
Discussion
The current phase II study (GOG protocol 205) specified cisplatin 40 mg/m2/week concurrent to radiation therapy. It also eliminated a planned treatment break and twice-daily radiation, and delivered a 20% higher dose of radiation (57.6 Gy) to the primary tumor than what was specified in GOG protocol 101 in hopes of achieving higher complete clinical and pathologic response rates, and improved local control rates, with acceptable treatment-related toxicity. In this regard, the results are superior
Conflict of interest statement
The authors wish to report that there are no conflicts of interest with the exception of Dr. Walker who reports a financial relationship with Abbott Laboratories.
Acknowledgements
This study was supported in part by National Cancer Institute grants to the Gynecologic Oncology Group Administrative Office (CA 27469) and the Gynecologic Oncology Group Statistical and Data Center (CA 37517).
The following GOG member institutions participated in this translational research study: University of Alabama at Birmingham, Abington Memorial Hospital, Walter Reed Army Medical Center, University of Minnesota Medical School, University of Washington, University of Cincinnati, University
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