Phase I study to determine the MTD of paclitaxel given three times per week during concurrent radiation therapy for stage III non-small cell lung cancer

Shi, Anhui; An, Tongtong; Zhu, Guangying; Yu, Rong; Xu, Gang; Liu, Xuyi; Xu, Bo

doi:10.1185/030079907x187874

Cited by 1 publication

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“…Enrolled patients were randomly assigned to one of the two treatment arms using the published maximum tolerated dose (18). CCRT was initiated 4–8 weeks after completion of induction chemotherapy.…”

Section: Methodsmentioning

confidence: 99%

“…This clinical trial has reported promising tumor response rates and a high rate of infield tumor control with low toxicities (15–17). We also conducted a phase 1 clinical study testing this hypothesis-based study design in China (18). Following up the phase 1 study, we conducted a multicenter randomized phase 3 study comparing two low-dose sensitizing paclitaxel schedules of CCRT for LA-NSCLC.…”

Section: Introductionmentioning

confidence: 99%

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Phase 3 Randomized Low-Dose Paclitaxel Chemoradiotherapy Study for Locally Advanced Non-Small Cell Lung Cancer

Lin¹,

Chen

Shi

et al. 2016

Front. Oncol.

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IntroductionConcurrent chemoradiotherapy (CCRT) is the standard treatment for locally advanced non-small cell lung cancer (LA-NSCLC) but is associated with poor chest tumor control. Here, we report results of a randomized phase 3 study comparing two CCRT regimens in improving chest tumor control by low-dose paclitaxel chemoradiation for LA-NSCLC.MethodsDue to the logistics of local referral pattern, the study was designed to enroll patients with stage III LA-NSCLC who had completed 2–4 cycles of full-dose chemotherapy. One hundred thirty four were randomized to either Arm 1 [paclitaxel at 15 mg/m2, three times per week (Monday, Wednesday, and Friday) for 6 weeks, n = 74] or Arm 2 (weekly paclitaxel at 45 mg/m2 for 6 weeks, n = 60). Chest radiotherapy was 60–70 Gy in standard fractionation. Response rate was the primary endpoint, with recurrence-free survival (RFS) as the secondary endpoint.ResultsFrom March 2006 to February 2013, 71 patients completed Arm 1 treatment and 59 completed Arm 2 treatment. The response rate for Arm 1 was significantly higher (83.1%) than Arm 2 (54.2%) (p=0.001). RFS was superior in Arm 1: median 14.6 vs. 9.4 months, p = 0.005, Hazard ratio (HR) 1.87 [95% confidence interval (CI) 1.20, 2.90]. Overall survival was not significantly different: median 32.6 months in Arm 1 vs. 31.3 months in Arm 2, p = 0.91, HR 0.97 (95% CI 0.55, 1.70). Toxicity was significantly lower in Arm 1 for Grade 3 and 4 leukopenia/neutropenia (p < 0.001).ConclusionPulsed low-dose paclitaxel CCRT resulted in significantly better RFS and tumor response rate, and less hematologic toxicities than weekly CCRT for LA-NSCLC.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Phase 3 Randomized Low-Dose Paclitaxel Chemoradiotherapy Study for Locally Advanced Non-Small Cell Lung Cancer

Lin¹,

Chen

Shi

et al. 2016

Front. Oncol.

Self Cite

View full text Add to dashboard Cite

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Phase I study to determine the MTD of paclitaxel given three times per week during concurrent radiation therapy for stage III non-small cell lung cancer

Abstract: 15 mg/m2 of paclitaxel, three times a week, concurrently with 3D-conformal radiotherapy for patients with locally advanced NSCLC after 2 or 3 cycles of induction chemotherapy is a safe and effective dose, according to our preliminary study.

Cited by 1 publication

References 25 publications

Phase 3 Randomized Low-Dose Paclitaxel Chemoradiotherapy Study for Locally Advanced Non-Small Cell Lung Cancer

Phase 3 Randomized Low-Dose Paclitaxel Chemoradiotherapy Study for Locally Advanced Non-Small Cell Lung Cancer

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