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Phase II Multicenter Study of Induction Chemotherapy Followed by Concurrent Efaproxiral (RSR13) and Thoracic Radiotherapy for Patients With Locally Advanced Non–Small-Cell Lung Cancer

From the Vanderbilt University Medical Center, Nashville, TN; Centre Hôspitalier Universitaire de Sherbrooke, Sherbrooke; Hôpital Notre Dame; Montreal General Hospital; Jewish General Hospital, Montreal, Québec; Cross Cancer Institute, Edmonton; Tom Baker Cancer Centre, Calgary, Alberta, Canada; University of Arizona Health Sciences Center, Tucson, AZ; Radiation Therapy Oncology Group; Thomas Jefferson University, Philadelphia, PA; Johns Hopkins Hospital, Baltimore, MD; Tower Hematology/Oncology, Los Angeles, CA; University of Louisville, Louisville, KY; Allos Therapeutics Inc, Westminster, CO

Address reprint requests to Hak Choy, MD, University of Texas Southwestern Medical Center at Dallas, 5323 Harry Hines Blvd, Building NF3.312B, Mail Code 9183, Dallas, TX 75390-9003; e-mail: hak.choy{at}utsouthwestern.edu

PURPOSE: Efaproxiral (RSR13) reduces hemoglobin oxygen–binding affinity, facilitates oxygen release, and increases tissue pO₂. We conducted a phase II multicenter study that assessed the efficacy and safety of efaproxiral when administered with thoracic radiation therapy (TRT), following induction chemotherapy, for treatment of locally advanced non–small-cell lung cancer (NSCLC).

PATIENTS AND METHODS: Fifty-one patients with locally advanced NSCLC were enrolled at 13 sites. Treatment comprised two cycles of paclitaxel (225 mg/m²) and carboplatin (area under the curve, 6), 3 weeks apart, followed by TRT (64 Gy/32 fractions) with concurrent efaproxiral (50 to 100 mg/kg). Survival results were compared with results of study Radiation Therapy Oncology Group (RTOG) 94-10.

RESULTS: Overall response rate was 75% (37 of 49 patients). Complete and partial response rates were 6% (three of 49 patients) and 69% (34 of 49 patients), respectively. Median survival time (MST) was 20.6 months (95% CI, 14.0 to 24.2); overall survival rates at 1- and 2-years were 67% and 37%, respectively. Survival results were compared with the sequential (S-CRT) and concurrent (C-CRT) chemoradiotherapy arms of RTOG 94-10. MSTs for cases matched by stage, Karnofsky performance status, and age were: RT-010, 20.6 months; S-CRT, 15.1 months; and C-CRT, 17.9 months. Grade 3 to 4 toxicities related to efaproxiral that occurred in more than one patient included transient hypoxemia (19%), radiation pneumonitis (11%), and fatigue (4%).

CONCLUSION: Addition of efaproxiral to S-CRT represents a promising approach in NSCLC treatment, and a randomized study should be pursued. The low incidence of grade 3 to 4 toxicities suggests that the use of efaproxiral instead of a cytotoxic agent, as a radiation sensitizer, may be advantageous.

Supported by Allos Therapeutics Inc, Westmister, CO.

Presented in part at the 10th World Conference on Lung Cacer, Vancouver, BC, August 2003; Federation of European Cancer Societies, Copenhagen, Denmark, September 2003.

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

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