Preliminary analysis of a phase II study of paclitaxel, carboplatin, and hyperfractionated radiation therapy for locally advanced inoperable non- small cell lung cancer

H. Choy, R. F. DeVore, K. R. Hande, L. L. Porter, P. Rosenblatt, F. Yunus, L. Schlabach, C. Smith, Y. Shyr, K. LaPorte, D. H. Johnson

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Abstract

We conducted a prospective phase II study to determine the response rate, toxicity profile, and survival rate among patients with locally advanced unresectable non-small cell lung cancer receiving concurrent weekly paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ), carboplatin, and hyperfractionated radiation therapy followed by two cycles of adjuvant paclitaxel and carboplatin. The weekly paclitaxel/carboplatin regimen was designed to optimize the radiosensitizing properties of paclitaxel during the concurrent phase of treatment. Thirty-two patients with unresectable stage IIIA and IIIB non-small cell lung cancer from Vanderbilt Cancer Center Affiliate Network institutions entered the study from June 1996 until February 1997. Weekly intravenous paclitaxel (50 mg/m2 over 1 hour) and weekly carboplatin (area under the concentration-time curve of 2) plus concurrent hyperfractionated chest radiotherapy (1.2 Gy twice daily [69.6 Gy total]) delivered for 6 weeks were followed by two cycles of paclitaxel (200 mg/m2) and carboplatin (area under the concentration-time curve of 6). Among 22 patients evaluable for response, one (4.5%) achieved a complete response and 16 (72.7%) achieved partial response, for an overall response rate of 77%. Among 23 patients evaluable for toxicity, esophagitis was the principal finding: grade 3 or 4 esophagitis occurred in eight patients (35%). Grade 3 and 4 pulmonary toxicities each occurred in 26% of patients. Thus, weekly paclitaxel/carboplatin plus concurrent hyperfractionated radiotherapy is a well-tolerated outpatient regimen with an encouraging response rate that is at least equivalent to more toxic chemoradiation regimens. These findings indicate that further clinical evaluation of weekly paclitaxel/carboplatin/hyperfractionated radiotherapy is warranted in phase III trials.

Original languageEnglish (US)
JournalSeminars in Oncology
Volume24
Issue number4 SUPPL.12
StatePublished - 1997

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Carboplatin
Paclitaxel
Non-Small Cell Lung Carcinoma
Radiotherapy
Esophagitis
Poisons
Outpatients
Thorax
Survival Rate
Lung

ASJC Scopus subject areas

  • Oncology

Cite this

Preliminary analysis of a phase II study of paclitaxel, carboplatin, and hyperfractionated radiation therapy for locally advanced inoperable non- small cell lung cancer. / Choy, H.; DeVore, R. F.; Hande, K. R.; Porter, L. L.; Rosenblatt, P.; Yunus, F.; Schlabach, L.; Smith, C.; Shyr, Y.; LaPorte, K.; Johnson, D. H.

In: Seminars in Oncology, Vol. 24, No. 4 SUPPL.12, 1997.

Research output: Contribution to journalArticle

Choy, H, DeVore, RF, Hande, KR, Porter, LL, Rosenblatt, P, Yunus, F, Schlabach, L, Smith, C, Shyr, Y, LaPorte, K & Johnson, DH 1997, 'Preliminary analysis of a phase II study of paclitaxel, carboplatin, and hyperfractionated radiation therapy for locally advanced inoperable non- small cell lung cancer', Seminars in Oncology, vol. 24, no. 4 SUPPL.12.
Choy, H. ; DeVore, R. F. ; Hande, K. R. ; Porter, L. L. ; Rosenblatt, P. ; Yunus, F. ; Schlabach, L. ; Smith, C. ; Shyr, Y. ; LaPorte, K. ; Johnson, D. H. / Preliminary analysis of a phase II study of paclitaxel, carboplatin, and hyperfractionated radiation therapy for locally advanced inoperable non- small cell lung cancer. In: Seminars in Oncology. 1997 ; Vol. 24, No. 4 SUPPL.12.
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abstract = "We conducted a prospective phase II study to determine the response rate, toxicity profile, and survival rate among patients with locally advanced unresectable non-small cell lung cancer receiving concurrent weekly paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ), carboplatin, and hyperfractionated radiation therapy followed by two cycles of adjuvant paclitaxel and carboplatin. The weekly paclitaxel/carboplatin regimen was designed to optimize the radiosensitizing properties of paclitaxel during the concurrent phase of treatment. Thirty-two patients with unresectable stage IIIA and IIIB non-small cell lung cancer from Vanderbilt Cancer Center Affiliate Network institutions entered the study from June 1996 until February 1997. Weekly intravenous paclitaxel (50 mg/m2 over 1 hour) and weekly carboplatin (area under the concentration-time curve of 2) plus concurrent hyperfractionated chest radiotherapy (1.2 Gy twice daily [69.6 Gy total]) delivered for 6 weeks were followed by two cycles of paclitaxel (200 mg/m2) and carboplatin (area under the concentration-time curve of 6). Among 22 patients evaluable for response, one (4.5{\%}) achieved a complete response and 16 (72.7{\%}) achieved partial response, for an overall response rate of 77{\%}. Among 23 patients evaluable for toxicity, esophagitis was the principal finding: grade 3 or 4 esophagitis occurred in eight patients (35{\%}). Grade 3 and 4 pulmonary toxicities each occurred in 26{\%} of patients. Thus, weekly paclitaxel/carboplatin plus concurrent hyperfractionated radiotherapy is a well-tolerated outpatient regimen with an encouraging response rate that is at least equivalent to more toxic chemoradiation regimens. These findings indicate that further clinical evaluation of weekly paclitaxel/carboplatin/hyperfractionated radiotherapy is warranted in phase III trials.",
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AU - Hande, K. R.

AU - Porter, L. L.

AU - Rosenblatt, P.

AU - Yunus, F.

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AU - Smith, C.

AU - Shyr, Y.

AU - LaPorte, K.

AU - Johnson, D. H.

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