Pilot Study of Accelerated Radiotherapy With Concurrent Chemotherapy for Stage III Non-Small Cell Lung Cancer
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Patients and methods
Eligible patients were required to have stage III (or medically inoperable stage II) NCSLC with no potential for curative resection, based on multidisciplinary, lung cancer tumor board discussion. Other requirements included Karnofsky Performance status ≥80%; weight loss ≤10%; absolute neutrophil count >2,000 cells/mm3; platelet count >100,000; forced expiratory volume in the first second (FEV1) > 1.25 L; serum creatinine <2 mg/dL; and bilirubin <1.5 mg/dL. In addition, patients with
Results
The study commenced in December 2001, and was closed to new accrual (despite protocol modifications) in December 2002. Five patients were enrolled and began protocol therapy; four are evaluable. (One patient was withdrawn because of noncompliance, and was found to have brain metastases before completion of thoracic RT.)
All of the four evaluable patients completed concurrent chemoRT on schedule, and did not develop esophagitis grade 3 or other severe acute chemoRT-induced toxicity. There were no
Discussion
The regimen used in this protocol was not feasible because of two unexpected problems. First, although acute toxicity during concurrent chemoRT was tolerable, two of four evaluable patients developed unacceptable subacute/late RT complications, one of which probably contributed to the patient’s death (fistula). Second, myelosuppression during the post-RT consolidation chemotherapy portion of the study was too excessive to allow reliable delivery, as originally planned.
The occurrence of two
Conclusion
The trial reported herein of accelerated concomitant boost chemoRT followed by systemic chemotherapy was excessively toxic and not feasible. Extreme caution must be used when combining dose-intensified RT with “standard” chemotherapy. Future studies should probably emphasize smaller RT field size and/or fraction size as is currently underway in RTOG 0117, which has now reopened as a phase II trial with a conventional dose-fractionation schedule (74 Gy in 7.5 weeks).
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