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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
- Source :
- Journal of Clinical Oncology. 23:5918-5928
- Publication Year :
- 2005
- Publisher :
- American Society of Clinical Oncology (ASCO), 2005.
-
Abstract
- 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.
- Subjects :
- Adult
Male
Radiation-Sensitizing Agents
Cancer Research
medicine.medical_specialty
Lung Neoplasms
Paclitaxel
medicine.medical_treatment
Urology
Carboplatin
chemistry.chemical_compound
Carcinoma, Non-Small-Cell Lung
Antineoplastic Combined Chemotherapy Protocols
medicine
Humans
Infusions, Intravenous
Lung cancer
Survival analysis
Aged
Chemotherapy
Aniline Compounds
business.industry
Area under the curve
Induction chemotherapy
Middle Aged
medicine.disease
Combined Modality Therapy
Survival Analysis
Radiation therapy
Oncology
chemistry
Efaproxiral
Female
Propionates
business
Nuclear medicine
medicine.drug
Subjects
Details
- ISSN :
- 15277755 and 0732183X
- Volume :
- 23
- Database :
- OpenAIRE
- Journal :
- Journal of Clinical Oncology
- Accession number :
- edsair.doi.dedup.....658cd57d761b5eea8344e4fcc6f15fd3