A prospective phase III study of three weekly versus weekly paclitaxel as second line therapy in advanced non small cell lung cancer

Date

19 Dec 2015

Session

Thoracic cancers

Presenters

Akhil Kapoor

Citation

Annals of Oncology (2015) 26 (suppl_9): 125-147. 10.1093/annonc/mdv532

Authors

N. Kumar1, A. Kapoor2, A. Kalwar3, S. Narayan4, M.K. Singhal5, A. Kumar6, S. Lal7

Author affiliations

  • 1 Clinical Oncology, Delhi State Cancer Institute, 110058 - New Delhi/IN
  • 2 Radiation Oncology, Acharya Tulsi Regional Cancer Treatment & Research Institute, 334003 - Bikaner/IN
  • 3 Oncology, SN Medical College, 342001 - Jodhpur/IN
  • 4 Radiation Oncology, Acharya Tulsi Cancer Treatment & Research Institut, 334001 - Bikaner/IN
  • 5 Department Of Radiation Oncology, Acharya Tulsi Cancer Treatment & Research Institut, 334001 - Bikaner/IN
  • 6 Mbbs - Student, SSG Hospital & Medical College, 390001 - Vadodara/IN
  • 7 Mbbs - Intern, Sardar Patel Medical College, 334003 - Bikaner/IN
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Aim/Background

Selected patients with good responses to first-line chemotherapy, good performance status, and a long disease-free period between initial chemotherapy and relapse are the candidates for second-line chemotherapy with taxane based regimen. The aim of this study was to evaluate the efficacy of three weekly versus weekly paclitaxel as second line therapy in previously treated patients of advanced non small cell lung cancer (NSCLC) in patient population.

Methods

Between October 2012 and December 2013, previously platinum based chemotherapy treated patients with stage IIIB/IV NSCLC were randomized 1:1 to three weekly paclitaxel (175 mg/m2 for 4 cycles) or weekly paclitaxel (80 mg/m2 for 3 months). The primary endpoint was the comparison of progression free survival (PFS) between the two arms and the secondary endpoints included overall survival (OS) and toxicity analyses. All statistical analyses were performed by using SPSS version 20.0.

Results

109 patients were enrolled in this study (median age: 59 years, males 78.8%, stage IV disease 70.6%, ECOG performance status 0/1: 66.9%). The patients were randomized in the three weekly paclitaxel (n = 55) and weekly paclitaxel (n = 54) arms. Median PFS for three weekly paclitaxel versus weekly paclitaxel was 3.1 vs. 4.3 months (hazard ratio [HR], 1.42; 95% CI, 1.07-1.75; P = 0.03), and median OS was 6.8 vs. 7.6 months (HR, 1.19; 95% CI, 0.79 to 1.29; P = 0.47), respectively. Weekly paclitaxel was well tolerated with grade 3-4 neutropenia (5.5% vs. 8.6%, P = 0.07) and grade 3-4 diarrhea (5.5% vs. 3.8%, P = 0.78).

Conclusions

Weekly paclitaxel demonstrated better PFS in comparison to conventional three weekly paclitaxel as second line therapy in patients with advanced non small cell lung cancer with acceptable toxicity profile. However, it failed to reach the significance level for overall survival benefit.

Clinical trial identification

Disclosure

All authors have declared no conflicts of interest.

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