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Study of paclitaxel, etoposide, and cisplatin chemotherapy combined with twice-daily thoracic radiotherapy for patients with limited-stage small-cell lung cancer: a Radiation Therapy Oncology Group 9609 phase II study.
J Clin Oncol. 2005 Aug 01; 23(22):4991-8.JC

Abstract

PURPOSE

To determine the response rate, progression-free survival and overall survival, and toxicity of paclitaxel, etoposide, and cisplatin combined with accelerated hyperfractionated thoracic radiotherapy in patients with limited-disease (LD) small-cell lung cancer (SCLC).

PATIENTS AND METHODS

LD-SCLC patients with measurable disease, Karnofsky performance score of > or = 70, and adequate organ function who were previously untreated were eligible for the study. Treatment was as follows. In cycle 1 of chemotherapy, concurrent thoracic radiation therapy was administered. In cycles 2 to 4, chemotherapy was administered alone. In cycle 1, chemotherapy consisted of paclitaxel 135 mg/m(2) intravenous over 3 hours on day 1, etoposide 60 mg/m(2) intravenous on day 1 and 80 mg/m(2) orally on days 2 and 3, and cisplatin 60 mg/m(2) intravenous on day 1. In cycles 2 to 4, the paclitaxel dose was increased to 175 mg/m(2), with the etoposide and cisplatin doses remaining the same as in cycle 1. The thoracic radiation therapy consisted of 1.5 Gy in 30 fractions (total dose, 45 Gy) administered 5 days a week for 3 weeks.

RESULTS

Fifty-five patients were enrolled onto the study, and 53 were assessable. The major toxicities included grade 3 and 4 acute neutropenia (32% and 43%, respectively) and grade 3 and 4 esophagitis (32% and 4%, respectively). Two patients died as a result of therapy (one died of acute respiratory distress syndrome, and one died of sepsis). There was one late fatal pulmonary toxicity. The median survival time was 24.7 months. The 2-year survival rate was 54.7%. The median progression-free survival time was 13 months, with a 2-year progression-free survival rate of 26.4%.

CONCLUSION

Although this therapeutic regimen is effective in the treatment of patients with LD-SCLC, it is unlikely that the three-drug combination with thoracic radiation therapy will improve the survival times compared with the etoposide plus cisplatin chemotherapy regimen with thoracic radiation therapy in LD-SCLC patients.

Authors+Show Affiliations

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD 21231-1000, USA. ettinda@jhmi.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Clinical Trial, Phase II
Journal Article
Multicenter Study
Research Support, N.I.H., Extramural
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

15939930

Citation

Ettinger, David S., et al. "Study of Paclitaxel, Etoposide, and Cisplatin Chemotherapy Combined With Twice-daily Thoracic Radiotherapy for Patients With Limited-stage Small-cell Lung Cancer: a Radiation Therapy Oncology Group 9609 Phase II Study." Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, vol. 23, no. 22, 2005, pp. 4991-8.
Ettinger DS, Berkey BA, Abrams RA, et al. Study of paclitaxel, etoposide, and cisplatin chemotherapy combined with twice-daily thoracic radiotherapy for patients with limited-stage small-cell lung cancer: a Radiation Therapy Oncology Group 9609 phase II study. J Clin Oncol. 2005;23(22):4991-8.
Ettinger, D. S., Berkey, B. A., Abrams, R. A., Fontanesi, J., Machtay, M., Duncan, P. J., Curran, W. J., Movsas, B., & Byhardt, R. W. (2005). Study of paclitaxel, etoposide, and cisplatin chemotherapy combined with twice-daily thoracic radiotherapy for patients with limited-stage small-cell lung cancer: a Radiation Therapy Oncology Group 9609 phase II study. Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, 23(22), 4991-8.
Ettinger DS, et al. Study of Paclitaxel, Etoposide, and Cisplatin Chemotherapy Combined With Twice-daily Thoracic Radiotherapy for Patients With Limited-stage Small-cell Lung Cancer: a Radiation Therapy Oncology Group 9609 Phase II Study. J Clin Oncol. 2005 Aug 1;23(22):4991-8. PubMed PMID: 15939930.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Study of paclitaxel, etoposide, and cisplatin chemotherapy combined with twice-daily thoracic radiotherapy for patients with limited-stage small-cell lung cancer: a Radiation Therapy Oncology Group 9609 phase II study. AU - Ettinger,David S, AU - Berkey,Brian A, AU - Abrams,Ross A, AU - Fontanesi,James, AU - Machtay,Mitchell, AU - Duncan,Philip J, AU - Curran,Walter J,Jr AU - Movsas,Benjamin, AU - Byhardt,Roger W, AU - ,, Y1 - 2005/06/06/ PY - 2005/6/9/pubmed PY - 2005/9/15/medline PY - 2005/6/9/entrez SP - 4991 EP - 8 JF - Journal of clinical oncology : official journal of the American Society of Clinical Oncology JO - J. Clin. Oncol. VL - 23 IS - 22 N2 - PURPOSE: To determine the response rate, progression-free survival and overall survival, and toxicity of paclitaxel, etoposide, and cisplatin combined with accelerated hyperfractionated thoracic radiotherapy in patients with limited-disease (LD) small-cell lung cancer (SCLC). PATIENTS AND METHODS: LD-SCLC patients with measurable disease, Karnofsky performance score of > or = 70, and adequate organ function who were previously untreated were eligible for the study. Treatment was as follows. In cycle 1 of chemotherapy, concurrent thoracic radiation therapy was administered. In cycles 2 to 4, chemotherapy was administered alone. In cycle 1, chemotherapy consisted of paclitaxel 135 mg/m(2) intravenous over 3 hours on day 1, etoposide 60 mg/m(2) intravenous on day 1 and 80 mg/m(2) orally on days 2 and 3, and cisplatin 60 mg/m(2) intravenous on day 1. In cycles 2 to 4, the paclitaxel dose was increased to 175 mg/m(2), with the etoposide and cisplatin doses remaining the same as in cycle 1. The thoracic radiation therapy consisted of 1.5 Gy in 30 fractions (total dose, 45 Gy) administered 5 days a week for 3 weeks. RESULTS: Fifty-five patients were enrolled onto the study, and 53 were assessable. The major toxicities included grade 3 and 4 acute neutropenia (32% and 43%, respectively) and grade 3 and 4 esophagitis (32% and 4%, respectively). Two patients died as a result of therapy (one died of acute respiratory distress syndrome, and one died of sepsis). There was one late fatal pulmonary toxicity. The median survival time was 24.7 months. The 2-year survival rate was 54.7%. The median progression-free survival time was 13 months, with a 2-year progression-free survival rate of 26.4%. CONCLUSION: Although this therapeutic regimen is effective in the treatment of patients with LD-SCLC, it is unlikely that the three-drug combination with thoracic radiation therapy will improve the survival times compared with the etoposide plus cisplatin chemotherapy regimen with thoracic radiation therapy in LD-SCLC patients. SN - 0732-183X UR - https://www.unboundmedicine.com/medline/citation/15939930/Study_of_paclitaxel_etoposide_and_cisplatin_chemotherapy_combined_with_twice_daily_thoracic_radiotherapy_for_patients_with_limited_stage_small_cell_lung_cancer:_a_Radiation_Therapy_Oncology_Group_9609_phase_II_study_ L2 - http://ascopubs.org/doi/full/10.1200/JCO.2005.00.414?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -