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Phase II Trial of Preoperative Chemoradiation in Patients With Localized Gastric Adenocarcinoma (RTOG 9904): Quality of Combined Modality Therapy and Pathologic Response

Jaffer A. Ajani, Kathryn Winter, Gordon S. Okawara, John H. Donohue, Peter W.T. Pisters, Christopher H. Crane, John F. Greskovich, P. Rani Anne, Jeffrey D. Bradley, Christopher Willett, Tyvin A. Rich

From the Department of Gastrointestinal Medical Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, TX; Radiation Therapy Oncology Group Headquarters; Thomas Jefferson University Hospital, Philadelphia, PA; McMaster University, Hamilton, Ontario, Canada; Mayo Clinic, Rochester, MN; University Hospitals, Cleveland, OH; Washington University School of Medicine, St Louis, MO; Duke University Medical Center, Durham, NC; and the University of Virginia, Charlottesville, VA

Address reprint requests to Jaffer A. Ajani, MD, Department of Gastrointestinal Medical Oncology, The University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030-4009; e-mail: Jajani{at}mdanderson.org

PURPOSE: Preoperative therapy for localized gastric cancer has considerable appeal. We hypothesized that, in a cooperative group setting, preoperative chemoradiotherapy would induce a 20% pathologic complete response (pathCR) rate. Combined-modality therapy quality, survival, and safety were secondary end points.

PATIENTS AND METHODS: Patients with localized gastric adenocarcinoma were eligible. A negative laparoscopic evaluation was required. Patients received two cycles of induction fluorouracil, leucovorin, and cisplatin followed by concurrent radiation and chemotherapy (infusional fluorouracil and weekly paclitaxel). Resection was attempted 5 to 6 weeks after chemoradiotherapy was completed. Quality of therapy was assessed with other end points.

RESULTS: Twenty institutions participated. Forty-nine patients were entered and 43 were assessable (12% stage IB; 37% stage II; and 52% stage III). The pathCR and R0 resection rates were 26% and 77%, respectively. At 1 year, more patients with pathCR (82%) are living than those with less than pathCR (69%). Grade 4 toxicity occurred in 21% of patients. Chemotherapy, radiotherapy, and surgery per protocol (including acceptable variations) occurred in 98%, 44%, and 63% of patients, respectively. A D2 dissection was performed in 50% of patients. Of 18 major radiotherapy variations, 17 were due to the lack of inclusion of the L3-4 vertebral interphase as prespecified.

CONCLUSION: For localized gastric cancer, preoperative chemoradiotherapy strategy achieved a pathCR rate of more than 20% in a cooperative group setting. The quality of surgery improved (50% with D2 dissection) possibly because surgery was part of this trial. With some refinements, this preoperative chemoradiotherapy strategy is poised for a randomized comparison with postoperative adjuvant chemoradiotherapy in patients with gastric cancer.

Supported by Radiation Therapy Oncology Group (RTOG) U10 Grants No. CA21661, CCOP U10 CA37422, and Stat U10 CA32115 from the National Cancer Institute (NCI). This manuscript's contents are the sole responsibility of the authors and do not necessarily represent the official views of the NCI.

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

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