Normal view MARC view ISBD view

LBA10 - A randomized investigator initiated phase III study comparing low dose gemcitabine to standard dose gemcitabine with platinum in advanced squamous non driver mutated non-small cell lung cancer

In Annals of Oncology
By: Chandrashekharan A.
Contributor(s): Patil V | Noronha V | Joshi A | Choughle A | Punatar S | Mahajan A | Janu A | Purandare N | Goud S | More S | Das S | Agrawal A | Rajourohit A | Majumdar S | Khaddar S | Prabhash K.
Material type: materialTypeLabelArticlePublisher: 2018Description: .Subject(s): Prolonged infusion | Non-small cell lung cancer (NSCLC) In: Annals of OncologySummary: Background: Prolonged infusion of low dose gemcitabine (PLDG) in combination with platinum has shown promising activity in terms of improved response rate and progression free survival (PFS); especially in squamous non-small cell lung cancer (NSCLC). In addition PLDG had additional advantage of decreasing the requirement of drug by 75% per dose. Hence, we conducted a phase 3 randomized non-inferiority study with the primary objective of comparing the overall survival (OS) between PLDG and standard dose gemcitabine with platinum in advanced squamous NSCLC. Methods: Adult subjects (age ≥ 18 years), with stage IIIB-IV, NSCLC, ECOG performance status of ≥ 2 and adequate organ function were randomized 1:1 into either carboplatin (AUC-5 intravenous over 30-60 minutes, Day 1) with standard dose gemcitabine (1000 mg/m2 intravenous over 30 minutes, Day 1 and 8) (STD-G arm) or the same schedule of carboplatin along with low dose gemcitabine (250 mg/m2 intravenous over 6 hours, Day 1 and 8) (LOW-G arm). Planned sample size was 308 for non-inferiority margin for upper limit of hazard ratio 1.33, assuming 80% power and one sided alpha of 0.05. Kaplan Meier method was used for estimation of OS and PFS and compared using log-rank test. A P value of 0.05 was considered as significant. Results: Out of the 308 patients randomised,155 and 153 patients were randomised in STD-G arm and LOW-G arm, respectively. At the time of data cutoff, 131 and127 patients had died in each arm, respectively. The median overall survival in STG-G arm was 204 days (95%CI 160-255) versus 251 days (95%CI 210-308) in LOW-G arm (P = 0.3). The hazard ratio for death was 0.890 (95%CI 0.697-1.137; P = 0.351). The median progression free survival in STG-G arm was 94 days (95%CI 80-123) versus 119 days (95%CI 92-137) in LOW-G arm (P = 0.658). The hazard ratio for progression was 0.949 (95%CI 0.752-1.197; P = 0.656). There was no statistical difference in adverse event rate between the 2 arms. Conclusions: This large phase 3 randomised study suggests that PLDG is an alternative to the standard gemcitabine schedule. It produces similar OS and PFS without an increase in adverse event rate.
TMC TMH
Tags from this library: No tags from this library for this title. Add tag(s)
Log in to add tags.
    average rating: 0.0 (0 votes)
Item type Current location Call number Status Date due Barcode
Articles Articles Tata Memorial Hospital
Available AR20019

Abstract Book of ESMO Asia Congress 23–25 November 2018, Singapore

Background: Prolonged infusion of low dose gemcitabine (PLDG) in combination with platinum has shown promising activity in terms of improved response rate and progression free survival (PFS); especially in squamous non-small cell lung cancer (NSCLC). In addition PLDG had additional advantage of decreasing the requirement of drug by 75% per dose. Hence, we conducted a phase 3 randomized non-inferiority study with the primary objective of comparing the overall survival (OS) between PLDG and standard dose gemcitabine with platinum in advanced squamous NSCLC.

Methods: Adult subjects (age ≥ 18 years), with stage IIIB-IV, NSCLC, ECOG performance status of ≥ 2 and adequate organ function were randomized 1:1 into either carboplatin (AUC-5 intravenous over 30-60 minutes, Day 1) with standard dose gemcitabine (1000 mg/m2 intravenous over 30 minutes, Day 1 and 8) (STD-G arm) or the same schedule of carboplatin along with low dose gemcitabine (250 mg/m2 intravenous over 6 hours, Day 1 and 8) (LOW-G arm). Planned sample size was 308 for non-inferiority margin for upper limit of hazard ratio 1.33, assuming 80% power and one sided alpha of 0.05. Kaplan Meier method was used for estimation of OS and PFS and compared using log-rank test. A P value of 0.05 was considered as significant.

Results: Out of the 308 patients randomised,155 and 153 patients were randomised in STD-G arm and LOW-G arm, respectively. At the time of data cutoff, 131 and127 patients had died in each arm, respectively. The median overall survival in STG-G arm was 204 days (95%CI 160-255) versus 251 days (95%CI 210-308) in LOW-G arm (P = 0.3). The hazard ratio for death was 0.890 (95%CI 0.697-1.137; P = 0.351). The median progression free survival in STG-G arm was 94 days (95%CI 80-123) versus 119 days (95%CI 92-137) in LOW-G arm (P = 0.658). The hazard ratio for progression was 0.949 (95%CI 0.752-1.197; P = 0.656). There was no statistical difference in adverse event rate between the 2 arms.

Conclusions: This large phase 3 randomised study suggests that PLDG is an alternative to the standard gemcitabine schedule. It produces similar OS and PFS without an increase in adverse event rate.

There are no comments for this item.

Log in to your account to post a comment.

Powered by Koha