Topotecan/cisplatin (TP) compared to cisplatin/etoposide (PE) for patients with extensive disease-small cell lung cancer (ED- SCLC): Final results of a randomised phase III trial.

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Abstracts

2008 ASCO Annual Meeting

Topotecan/cisplatin (TP) compared to cisplatin/etoposide (PE) for patients with extensive disease-small cell lung cancer (ED- SCLC): Final results of a randomised phase III trial.

Sub-category:

Adjuvant Therapy

Category:

Lung Cancer--Local-Regional and Adjuvant Therapy

Meeting:

2008 ASCO Annual Meeting

Session Type and Session Title:

null, General Session XIV: Lung Cancer - Small Cell Carcinoma
Oral Presentation, Lung Cancer — Local-Regional and Adjuvant Therapy

Abstract No:

7513

Citation:

J Clin Oncol 26: 2008 (May 20 suppl; abstr 7513)

Author(s):

D. F. Heigener, L. Freitag, C. Eschbach, R. M. Huber, T. Fink, S. Hummler, N. Banik, M. Wolf, ABC Study Group

Abstract:

Background: This phase III study was conducted to evaluate the efficacy and safety of TP compared to the standard first- line regimen PE. Methods: Chemotherapy-naïve patients with confirmed ED-SCLC and ECOG performance status < 2 were randomised to receive topotecan (1mg/m² i.v., d1-5)/cisplatin (75 mg/m² i.v., d5) or etoposide (100mg/m² i.v., d1-3)/cisplatin (75 mg/m² i.v., d1) for a maximum of 6 cycles, q 21 d. Primary objective was to show superiority in OS of TP compared to PE using a two sided log-rank test with a 5% type I error and 80% power. If superiority was not shown, a non-inferiority test was pre-specified (non-inferiority threshold was 10 percentage points relative to the median survival time in the standard arm). Secondary endpoints were 1 year survival rate, objective response rate, time to progression and safety. Results: 795 patients were recruited (358 TP, 345 PE, 92 TE) in 84 centres in Germany and Austria. Baseline characteristics were balanced. Median number of cycles was 6, both for TP and PE. A third study arm topotecan (1mg/m² i.v., d1-5)/etoposide (80-100 mg/m² i.v., d3-5) was abandoned in April 2004 following a recommendation of an IDSMB due to an increased number of treatment related deaths. Haematologic toxicity: TP vs. PE: G3/4 neutropenia (35.7/ 35.8%), Gr 3/4 thrombocytopenia (18.7/4.8%), Gr 3/4 anaemia (11.6/6.7%), febrile neutropenia (2.0/2.7%), sepsis (1.7/1.2%), toxicity related deaths (5.2/2.7%). Transfusions of red-cell units (420/ 153). Non-haematological toxicity was comparable. Conclusion: Topotecan/cisplatin (TP) is non inferior to cisplatin/etoposide (PE) in OS and is superior in TTP and ORR. TP may be considered as an alternative 1^st line treatment option for patients with ED-SCLC.Efficacy results (ITT unless indicated)

	TP	PE	p- value
Median survival (months) 99% CI - PP analysis	10.3 9.3-11.3	9.4 8.2-10.9	0.40
1- year survival rate 95% CI	39.7% 34.5% - 44.9%	36.1% 30.9% - 41.4%	0.29
Median TTP (months) 95% CI	6.9 6.4-7.3	5.9 5.5-6.6	0.004
CR 95% CI	9.5% 6.7% - 13.1%	6.9% 4.4% - 10.2%	0.21
ORR (CR+PR) 95% CI	55.5% 50.3% - 60.7%	45.5% 40.2% - 50.8%	0.01

Abstract Disclosures

Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy and are designated with a caret symbol (^) here and in the print version.

Associated Presentation(s):

1. Topotecan/cisplatin (TP) compared to cisplatin/etoposide (PE) for patients with extensive disease-small cell lung cancer (ED-SCLC): final results of a randomised phase III trial

Meeting: 2008 Best of ASCO Boston
Speaker: D. Heigener
Session: General Session XIV: Lung Cancer - Small Cell Carcinoma

2. Topotecan/cisplatin (TP) compared to cisplatin/etoposide (PE) for patients with extensive disease-small cell lung cancer (ED- SCLC): Final results of a randomised phase III trial.

Meeting: 2008 ASCO Annual Meeting
Presenter: David F Heigener, MD
Session: Lung Cancer — Local-Regional and Adjuvant Therapy (Oral Presentation)

Other Abstracts in this Sub-Category:

		1. Phase III study of pemetrexed plus carboplatin (PC) versus etoposide plus carboplatin (EC) in chemonaive patients (pts) with extensive-stage disease small cell lung cancer (ED-SCLC): Interim results Meeting: 2008 ASCO Annual Meeting Abstract No: NSA First Author: M.A. Socinski Category: Lung Cancer--Local-Regional and Adjuvant Therapy - Adjuvant Therapy
		2. Use of Ras effector RASSF1A promoter gene methylation and chromosome 9p loss of heterozygosity (LOH) to predict progression-free survival (PFS) in perioperative chemotherapy (CT) phase III trial IFCT-0002 in resectable non-small cell lung cancer. Meeting: 2008 ASCO Annual Meeting Abstract No: 7500 First Author: G. Zalcman Category: Lung Cancer--Local-Regional and Adjuvant Therapy - Adjuvant Therapy
		3. Association of gene expression signature and clinical efficacy of MAGE-A3 antigen-specific cancer immunotherapeutic (ASCI) as adjuvant therapy in resected stage IB/II non-small cell lung cancer (NSCLC). Meeting: 2008 ASCO Annual Meeting Abstract No: 7501 First Author: J. F. Vansteenkiste Category: Lung Cancer--Local-Regional and Adjuvant Therapy - Adjuvant Therapy
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Abstracts by D. F. Heigener :

		1. The cost-effectiveness of bevacizumab plus cisplatin and gemcitabine (BCG) compared with pemetrexed plus cisplatin (PC) induction treatment of advanced non-squamous non-small cell lung cancer (NSCLC) in Germany. Meeting: 2010 ASCO Annual Meeting Abstract No: e18054 First Author: H. Bischoff Category: Lung Cancer - Metastatic - Metastatic
		2. A cost analysis of treatment with bevacizumab plus cisplatin and gemcitabine (BCG) versus cetuximab plus vinorelbine and cisplatin (CVC) in patients with advanced or recurrent non-small cell lung cancer (NSCLC) in Germany. Meeting: 2009 ASCO Annual Meeting Abstract No: e17553 First Author: D. F. Heigener Category: Health Services Research
		3. Topotecan/cisplatin (TP) compared to cisplatin/etoposide (PE) for patients with extensive disease-small cell lung cancer (ED- SCLC): Final results of a randomised phase III trial. Meeting: 2008 ASCO Annual Meeting Abstract No: 7513 First Author: D. F. Heigener Category: Lung Cancer--Local-Regional and Adjuvant Therapy - Adjuvant Therapy
		More...

Presentations by D. F. Heigener :

1. Topotecan/cisplatin (TP) compared to cisplatin/etoposide (PE) for patients with extensive disease-small cell lung cancer (ED- SCLC): Final results of a randomised phase III trial.

Meeting: 2008 ASCO Annual Meeting
Presenter: David F Heigener, MD
Session: Lung Cancer — Local-Regional and Adjuvant Therapy (Oral Presentation)

More...

Educational Book Manuscripts by D. F. Heigener :

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