Dataset Information

Phase III Non-inferiority Study Evaluating Efficacy and Safety of Low Dose Gemcitabine Compared to Standard Dose Gemcitabine With Platinum in Advanced Squamous Lung Cancer.

ABSTRACT:

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). 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 of gemcitabine with platinum.

Methodology

Adult subjects (age ≥ 18 years), with stages IIIB-IV, NSCLC (squamous) and ECOG performance status of ≤ 2 were randomized 1:1 into either carboplatin with standard dose gemcitabine (1000 mg/m² intravenous over 30 min, days 1 and 8) (STD-G arm) or carboplatin along with low dose gemcitabine (250 mg/m² intravenous over 6 h, days 1 and 8) (LOW-G arm) for a maximum of 6 cycles. Tumor response was assessed by RECIST criteria version 1.1 every 2 cycles till 6th cycle and thereafter at 2 monthly intervals till progression. The primary endpoint was overall survival. 308 patients were randomized, 155 in STD-G arm and 153 in LOW-G arm, respectively.

Results

The median overall survival in STD-G arm was 6.8 months (95%CI 5.3-8.5) versus 8.4 months (95%CI 7-10.3) in the LOW-G arm (HR-0.890 (90%CI 0.725-1.092). The results with per protocol analysis were in line with these results. There was no statistical difference in progression free survival (HR-0.949; 90%CI 0.867-1.280) and adverse event rate between the 2 arms.

Conclusion

This study suggests that PLDG is an alternative to the standard gemcitabine schedule in squamous NSCLC, and either of these can be selected subject to patient convenience.

SUBMITTER: Patil V

PROVIDER: S-EPMC6510888 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Publications

Phase III Non-inferiority Study Evaluating Efficacy and Safety of Low Dose Gemcitabine Compared to Standard Dose Gemcitabine With Platinum in Advanced Squamous Lung Cancer.

Patil Vijay V Noronha Vanita V Joshi Amit A Chougule Anuradha A Kannan Sadhana S Bhattacharjee Atanu A Goud Supriya S More Sucheta S Chandrasekharan Arun A Menon Nandini N Srinivas Sujay S Vallathol Dilip Harindran DH Dsouza Hollis H Majumdar Swaratika S Das Sudeep S Zawar Abhinav A Khaddar Satvik S Kumar Amit A Singh Gunjesh G Kumar Kanteti Aditya Pavan KAP Ravind Rahul R Trivedi Vaishakhi V Behel Vichitra V Mahajan Abhishek A Janu Amit A Purandare Nilendu N Prabhash Kumar K

EClinicalMedicine 20190301

<h4>Background</h4>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). 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 of gemcitabine with platinum.<h4>Methodology</h4>Adult subjects (age ≥ 18 years), ...[more]

PMID: 31143878

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Dataset Information

Phase III Non-inferiority Study Evaluating Efficacy and Safety of Low Dose Gemcitabine Compared to Standard Dose Gemcitabine With Platinum in Advanced Squamous Lung Cancer.

Background

Methodology

Results

Conclusion

Publications

Phase III Non-inferiority Study Evaluating Efficacy and Safety of Low Dose Gemcitabine Compared to Standard Dose Gemcitabine With Platinum in Advanced Squamous Lung Cancer.

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