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Impact of adding concurrent chemotherapy to hyperfractionated radiotherapy for locally advanced non-small cell lung cancer (NSCLC): comparison of RTOG 83-11 and RTOG 91-06.

Abstract
A hyperfractionated radiation therapy (HFX RT) trial (1.2 Gy twice daily, b.i.d.) (HFX) for non-small cell lung cancer (NSCLC) showed that 69.6 Gy resulted in better survival than did lower total doses (Radiation Therapy Oncology Group, RTOG 83-11) and that cisplatin concurrent with irradiation improved local control and survival over RT alone (Radiation Therapy Oncology Group, RTOG 91-06). Concurrent combination chemotherapy and HFX could improve both local and systemic control. In a phase II trial (RTOG 91-06) for inoperable NSCLC, two cycles of PE were used [cisplatin 50 mg/m2 intravenously (i.v.) days 1 and 8, etoposide 50 mg orally (p.o.) b.i.d., 75 mg/day if body surface area (BSA) < 1.7 m2, days 1-14] starting on day 1 of HFX (69.6 Gy) and repeated on day 29. HFX/PE was compared with HFX (69.6 Gy) from an earlier phase II trial (RTOG 83-11). Seventy-six patients treated with HFX/PE and 203 patients who received HFX alone were compared for toxicity, response, survival, and patterns of failure. The rates of grade 4 nonhematologic toxicity were similar (3.0% for HFX/PE, 3.0% for HFX), but grade 4 hematologic toxicity occurred only with HFX/PE 56.6%. Three (3.9%) HFX/PE patients had fatal toxicity (2 pulmonary, 1 renal); 1 HFX patient had fatal esophageal toxicity. Response and metastasis rates were similar for the two treatments, but infield (p = 0.054) and overall (p = 0.04) progression-free survival rates were better with HFX/PE. Median survivals were 18.9 months with HFX/PE and 10.6 months with HFX. Two-year survival rates were 36% for HFX/PE and 22% for HFX (p = 0.014). The differences in survival between HFX/PE and HFX remained borderline statistically significant (p = 0.0593) in the multivariate model, which included weight loss, Karnofsky performance status (KPS), sex, and stage. HFX/PE is an effective regimen in patients with inoperable NSCLC, although it is considerably more toxic, and is undergoing a comparison in a three-arm randomized phase III study against induction cisplatin/vinblastine plus standard once-daily RT and against cisplatin/vinblastine concurrent with standard RT.
AuthorsR Komaki, C Scott, J S Lee, R C Urtasun, R W Byhardt, B Emami, E J Andras, S O Asbell, M Rotman, J D Cox
JournalAmerican journal of clinical oncology (Am J Clin Oncol) Vol. 20 Issue 5 Pg. 435-40 (Oct 1997) ISSN: 0277-3732 [Print] United States
PMID9345325 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Comparative Study, Journal Article, Randomized Controlled Trial)
Chemical References
  • Antineoplastic Agents
  • Antineoplastic Agents, Phytogenic
  • Vinblastine
  • Etoposide
  • Cisplatin
Topics
  • Administration, Oral
  • Antineoplastic Agents (administration & dosage, adverse effects)
  • Antineoplastic Agents, Phytogenic (administration & dosage, adverse effects)
  • Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects, therapeutic use)
  • Body Surface Area
  • Carcinoma, Non-Small-Cell Lung (drug therapy, radiotherapy)
  • Cause of Death
  • Cisplatin (administration & dosage, adverse effects)
  • Clinical Trials, Phase III as Topic
  • Combined Modality Therapy
  • Disease Progression
  • Dose Fractionation, Radiation
  • Etoposide (administration & dosage, adverse effects)
  • Female
  • Humans
  • Injections, Intravenous
  • Karnofsky Performance Status
  • Lung Neoplasms (drug therapy, radiotherapy)
  • Male
  • Middle Aged
  • Multivariate Analysis
  • Neoplasm Staging
  • Radiotherapy (adverse effects)
  • Radiotherapy Dosage
  • Remission Induction
  • Sex Factors
  • Survival Rate
  • Treatment Outcome
  • Vinblastine (administration & dosage)
  • Weight Loss

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