NSCLC

GEMZAR: For the 1st line treatment of NSCLC1

GEMZAR/cisplatin

Established efficacy
Consistent, proven evidence across the largest body of phase III trials*
Established tolerability profile
GEMZAR alone, or in combination with Cisplatin, is indicated for the first line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC).
View trial design for the first line treatment of NSCLC.

*The clinical trials reviewed to support this information were found by searching the Medline, Embase, and Cancerlit databases as of December 2008.


1Gemzar Product Insert. Eli Lilly Hong Kong, Inc. May 2011

Two randomised clinical studies support the use of GEMZAR/cisplatin for the 1st line treatment of patients with locally advanced or metastatic NSCLC1,2

Sandler study: GEMZAR/cisplatin vs cisplatin1

Large, multicentre, randomised phase III trial to compare efficacy, primarily in terms of overall survival of combination therapy versus monotherapy in patients with locally advanced or metastatic NSCLC1

Click here to view efficacy for locally advanced or metastatic NSCLC.

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Cardenal study: GEMZAR/cisplatin vs etoposide/cisplatin2

Multicentre, randomised phase III trial to compare efficacy, primarily in terms of response rate of 2 different platinum-based regimens in patients with locally advanced or metastatic NSCLC2

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1Sandler AB, et al. Phase III trial of gemcitabineplus cisplatinversus cisplatinalone in patients with locally advanced or metastatic non-small-cell lung cancer. J Clin Oncol. 2000;18:122-130.
2CardenalF, et al. Randomized phase III study of gemcitabine-cisplatinversus etoposide-cisplatinin the treatment of locally advanced or metastatic non–small-cell lung cancer. J Clin Oncol. 1999;17:12-18.

Established efficacy1

In a randomised, phase III trial of 522 patients with inoperable, locally advanced, or metastatic NSCLC, GEMZAR/cisplatin showed an extended median survival, prolongation of time to progression, and a statistically significant higher response rate compared with cisplatin alone.

Median overall survival
GEMZAR/cisplatin 9.1 months
Cisplatin 7.6 months

Time to progression
  • GEMZAR/cisplatin 5.6 months
  • Cisplatin 3.7 months

Click here to view tolerability for locally advanced or metastatic NSCLC. Gemzar

Sandler study: Overall response rate1

Significant improvement in overall response rate

GEMZAR/cisplatin 31 %
Cisplatin 12 %

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Cardenal study: Time to progression1

In another phase III trial of 135 patients with stage IIIB or IV NSCLC, a combination of GEMZAR/cisplatin demonstrated prolongation of the time to progression and statistically significant higher response rate versus etoposide/cisplatin.

Prolongation of the time to progression

GEMZAR/cisplatin 6.9 months
Etoposide/cisplatin 4.3 months

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Cardenal study: Overall response rate1

Significant improvement in overall response rate

GEMZAR/cisplatin 40.6 %
Etoposide/cisplatin 21.2 %

Gemzar

1Gemzar Product Insert. Eli Lilly Hong Kong, Inc. May 2011

Superior efficacy with a well-defined tolerability profile1,2

In both studies of locally advanced or metastatic NSCLC, it was found that tolerability was similar in the 2 treatment arms.

Click here to view dosing for locally advanced or metastatic NSCLC.

Gemzar
Cardenal study: Tolerability information

Grades 3/4 adverse events for GEMZAR/cisplatin versus etoposide/cisplatin.

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1Sandler AB, et al. Phase III trial of gemcitabineplus cisplatinversus cisplatinalone in patients with locally advanced or metastatic non –small-cell lung cancer. J Clin Oncol. 2000;18:122-130.
2CardenalF, et al. Randomized phase III study of gemcitabine-cisplatinversus etoposide-cisplatinin the treatment of locally advanced or metastatic non–small-cell lung cancer. J Clin Oncol. 1999;17:12-18.

Dosing of GEMZAR in advanced NSCLC1

GEMZAR is administered on Days 1 and 8 of each 21-day cycle. Cisplatinis administered once every 3 weeks.

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Dose modifications

Refer to the GEMZAR Prescribing Information for proper dose modifications for GEMZAR in combination with cisplatin.1

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1Gemzar Product Insert. Eli Lilly Hong Kong, Inc. May 2011.



Last Update: 25 Oct 15

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