Randomized phase II trial of gemcitabine plus weekly versus three-weekly paclitaxel in previously untreated advanced non-small-cell lung cancer

C. P. Belani, S. Dakhil, D. M. Waterhouse, C. E. Desch, D. K. Rooney, Romnee Clark, M. J. Monberg, Z. Ye, C. K. Obasaju

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

Introduction: Gemcitabine and paclitaxel (Taxol) each provides an efficacious non-platinum option for the treatment of advanced non-small-cell lung cancer (NSCLC), but the optimal dosage and schedule of the two agents used in combination are not well defined. Methods: Previously untreated patients with advanced NSCLC were randomized to receive gemcitabine-paclitaxel on a traditional three-weekly schedule (Arm A) or a novel weekly schedule (Arm B) as follows - Arm A (three-weekly): gemcitabine 1000 mg/m2 infused >30 min on days 1 and 8 and paclitaxel 200 mg/m2 infused >3 h on day 1 of a 21-day cycle or Arm B (weekly): gemcitabine 1000 mg/m2 infused >30 min and paclitaxel 100 mg/m2 infused >1 h, both administered on days 1 and 8 of a 21-day cycle. Results: One hundred patients received at least one dose of treatment. The weekly schedule, Arm B, was more efficacious and less hematologically toxic than Arm A. Confirmed complete and partial response rates were 28.2% and 26.8%, respectively. Median survival was 10.3 months on Arm B and 7.9 months on Arm A (log-rank P = 0.10); 1- and 2-year survival rates also favor Arm B: 42.0% versus 34.0% and 18.0% versus 6.0%. Progression-free survival was 5.8 versus 4.8 months, again favoring Arm B (log-rank P = 0.06). There was a two-fold lower frequency of grade 3/4 hematologic events with Arm B as follows: neutropenia (16% versus 30%), thrombocytopenia (4% versus 8%), and anemia (2% versus 6%). One patient (2%) in each treatment group developed febrile neutropenia. Conclusion: In this trial, both schedules were efficacious and tolerable, although the weekly schedule resulted in improved survival and lower hematologic toxicity compared with a three-weekly schedule. The weekly schedule of gemcitabine-paclitaxel indicates an improved therapeutic index.

Original languageEnglish (US)
Pages (from-to)110-115
Number of pages6
JournalAnnals of Oncology
Volume18
Issue number1
DOIs
StatePublished - Jan 2007
Externally publishedYes

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gemcitabine
Paclitaxel
Non-Small Cell Lung Carcinoma
Appointments and Schedules
Febrile Neutropenia
Survival
Poisons
Therapeutics
Neutropenia
Disease-Free Survival
Anemia

Keywords

  • Gemcitabine
  • Non-platinum doublets
  • Non-small-cell lung cancer
  • Paclitaxel

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Randomized phase II trial of gemcitabine plus weekly versus three-weekly paclitaxel in previously untreated advanced non-small-cell lung cancer. / Belani, C. P.; Dakhil, S.; Waterhouse, D. M.; Desch, C. E.; Rooney, D. K.; Clark, Romnee; Monberg, M. J.; Ye, Z.; Obasaju, C. K.

In: Annals of Oncology, Vol. 18, No. 1, 01.2007, p. 110-115.

Research output: Contribution to journalArticle

Belani, C. P. ; Dakhil, S. ; Waterhouse, D. M. ; Desch, C. E. ; Rooney, D. K. ; Clark, Romnee ; Monberg, M. J. ; Ye, Z. ; Obasaju, C. K. / Randomized phase II trial of gemcitabine plus weekly versus three-weekly paclitaxel in previously untreated advanced non-small-cell lung cancer. In: Annals of Oncology. 2007 ; Vol. 18, No. 1. pp. 110-115.
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abstract = "Introduction: Gemcitabine and paclitaxel (Taxol) each provides an efficacious non-platinum option for the treatment of advanced non-small-cell lung cancer (NSCLC), but the optimal dosage and schedule of the two agents used in combination are not well defined. Methods: Previously untreated patients with advanced NSCLC were randomized to receive gemcitabine-paclitaxel on a traditional three-weekly schedule (Arm A) or a novel weekly schedule (Arm B) as follows - Arm A (three-weekly): gemcitabine 1000 mg/m2 infused >30 min on days 1 and 8 and paclitaxel 200 mg/m2 infused >3 h on day 1 of a 21-day cycle or Arm B (weekly): gemcitabine 1000 mg/m2 infused >30 min and paclitaxel 100 mg/m2 infused >1 h, both administered on days 1 and 8 of a 21-day cycle. Results: One hundred patients received at least one dose of treatment. The weekly schedule, Arm B, was more efficacious and less hematologically toxic than Arm A. Confirmed complete and partial response rates were 28.2{\%} and 26.8{\%}, respectively. Median survival was 10.3 months on Arm B and 7.9 months on Arm A (log-rank P = 0.10); 1- and 2-year survival rates also favor Arm B: 42.0{\%} versus 34.0{\%} and 18.0{\%} versus 6.0{\%}. Progression-free survival was 5.8 versus 4.8 months, again favoring Arm B (log-rank P = 0.06). There was a two-fold lower frequency of grade 3/4 hematologic events with Arm B as follows: neutropenia (16{\%} versus 30{\%}), thrombocytopenia (4{\%} versus 8{\%}), and anemia (2{\%} versus 6{\%}). One patient (2{\%}) in each treatment group developed febrile neutropenia. Conclusion: In this trial, both schedules were efficacious and tolerable, although the weekly schedule resulted in improved survival and lower hematologic toxicity compared with a three-weekly schedule. The weekly schedule of gemcitabine-paclitaxel indicates an improved therapeutic index.",
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T1 - Randomized phase II trial of gemcitabine plus weekly versus three-weekly paclitaxel in previously untreated advanced non-small-cell lung cancer

AU - Belani, C. P.

AU - Dakhil, S.

AU - Waterhouse, D. M.

AU - Desch, C. E.

AU - Rooney, D. K.

AU - Clark, Romnee

AU - Monberg, M. J.

AU - Ye, Z.

AU - Obasaju, C. K.

PY - 2007/1

Y1 - 2007/1

N2 - Introduction: Gemcitabine and paclitaxel (Taxol) each provides an efficacious non-platinum option for the treatment of advanced non-small-cell lung cancer (NSCLC), but the optimal dosage and schedule of the two agents used in combination are not well defined. Methods: Previously untreated patients with advanced NSCLC were randomized to receive gemcitabine-paclitaxel on a traditional three-weekly schedule (Arm A) or a novel weekly schedule (Arm B) as follows - Arm A (three-weekly): gemcitabine 1000 mg/m2 infused >30 min on days 1 and 8 and paclitaxel 200 mg/m2 infused >3 h on day 1 of a 21-day cycle or Arm B (weekly): gemcitabine 1000 mg/m2 infused >30 min and paclitaxel 100 mg/m2 infused >1 h, both administered on days 1 and 8 of a 21-day cycle. Results: One hundred patients received at least one dose of treatment. The weekly schedule, Arm B, was more efficacious and less hematologically toxic than Arm A. Confirmed complete and partial response rates were 28.2% and 26.8%, respectively. Median survival was 10.3 months on Arm B and 7.9 months on Arm A (log-rank P = 0.10); 1- and 2-year survival rates also favor Arm B: 42.0% versus 34.0% and 18.0% versus 6.0%. Progression-free survival was 5.8 versus 4.8 months, again favoring Arm B (log-rank P = 0.06). There was a two-fold lower frequency of grade 3/4 hematologic events with Arm B as follows: neutropenia (16% versus 30%), thrombocytopenia (4% versus 8%), and anemia (2% versus 6%). One patient (2%) in each treatment group developed febrile neutropenia. Conclusion: In this trial, both schedules were efficacious and tolerable, although the weekly schedule resulted in improved survival and lower hematologic toxicity compared with a three-weekly schedule. The weekly schedule of gemcitabine-paclitaxel indicates an improved therapeutic index.

AB - Introduction: Gemcitabine and paclitaxel (Taxol) each provides an efficacious non-platinum option for the treatment of advanced non-small-cell lung cancer (NSCLC), but the optimal dosage and schedule of the two agents used in combination are not well defined. Methods: Previously untreated patients with advanced NSCLC were randomized to receive gemcitabine-paclitaxel on a traditional three-weekly schedule (Arm A) or a novel weekly schedule (Arm B) as follows - Arm A (three-weekly): gemcitabine 1000 mg/m2 infused >30 min on days 1 and 8 and paclitaxel 200 mg/m2 infused >3 h on day 1 of a 21-day cycle or Arm B (weekly): gemcitabine 1000 mg/m2 infused >30 min and paclitaxel 100 mg/m2 infused >1 h, both administered on days 1 and 8 of a 21-day cycle. Results: One hundred patients received at least one dose of treatment. The weekly schedule, Arm B, was more efficacious and less hematologically toxic than Arm A. Confirmed complete and partial response rates were 28.2% and 26.8%, respectively. Median survival was 10.3 months on Arm B and 7.9 months on Arm A (log-rank P = 0.10); 1- and 2-year survival rates also favor Arm B: 42.0% versus 34.0% and 18.0% versus 6.0%. Progression-free survival was 5.8 versus 4.8 months, again favoring Arm B (log-rank P = 0.06). There was a two-fold lower frequency of grade 3/4 hematologic events with Arm B as follows: neutropenia (16% versus 30%), thrombocytopenia (4% versus 8%), and anemia (2% versus 6%). One patient (2%) in each treatment group developed febrile neutropenia. Conclusion: In this trial, both schedules were efficacious and tolerable, although the weekly schedule resulted in improved survival and lower hematologic toxicity compared with a three-weekly schedule. The weekly schedule of gemcitabine-paclitaxel indicates an improved therapeutic index.

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