S0124: A randomized phase III trial comparing irinotecan/cisplatin (IP) with etoposide/cisplatin (EP) in patients (pts) with previously untreated extensive stage small cell lung cancer (E-SCLC).

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Abstracts

2008 ASCO Annual Meeting

S0124: A randomized phase III trial comparing irinotecan/cisplatin (IP) with etoposide/cisplatin (EP) in patients (pts) with previously untreated extensive stage small cell lung cancer (E-SCLC).

Sub-category:

Adjuvant Therapy

Category:

Lung Cancer--Local-Regional and Adjuvant Therapy

Meeting:

2008 ASCO Annual Meeting

Abstract No:

7512

Citation:

J Clin Oncol 26: 2008 (May 20 suppl; abstr 7512)

Author(s):

R. B. Natale, P. N. Lara, K. Chansky, J. J. Crowley, J. R. Jett, J. E. Carleton, J. P. Kuebler, H. J. Lenz, P. C. Mack, D. G. Gandara

Abstract:

Background: The role of irinotecan in SCLC remains controversial. Although J9511 demonstrated a significant survival benefit for IP over EP in Japanese pts with E-SCLC (Noda, et al. NEJM 2002), another small phase III trial did not (Hanna, et al JCO 2006). S0124 was designed to confirm the results of J9511 in a North American & to investigate the association of genetic polymorphisms (SNPs) with outcomes. Methods: Pts with documented E-SCLC, adequate end-organ function & controlled or no brain metastases were stratified by single vs multiple metastases, normal vs elevated LDH, & weight loss < 5% vs > 5%, & randomized to (IP) I-60 mg/m² days 1, 8, & 15 + P-60 mg/m² day 1, Q 4 weeks or (IP) E-100 mg/m² days 1-3 + P-80 mg/m² day 1, Q 3 weeks. A blood specimen for SNP analysis was collected pre- randomization. Results: From 11/02 through 3/07, 671 pts were accrued, with 645 eligible: IP (N=323) & EP (N=322). Pt demographics: median age 63, 57% males, 76% with multiple metastatic sites, 62% < 5% weight loss. Grade 3 + 4 toxicities in IP vs EP: neutropenia = 33% vs 64%, thrombocytopenia = 3.5% vs 14%, diarrhea = 19% vs 3%, infection = 12% vs 18%, cardiovascular = 11% vs 12%, renal = 3.8% vs 3.8% & hepatic = 2% vs 5%. There were 12 treatment related deaths on IP & 8 on EP. Efficacy data are summarized in the table below. SNPs, ABCBq*3435 T/T & UGT1A1*3156 A/A, were associated with an increased risk of grade 3+ diarrhea (p=.04) and neutropenia (p=.009), respectively, for IP, as previously described (Lara, ASCO 2007). Updated results will be presented. Conclusions: This large randomized trial failed to confirm the positive results of J9511. IP & EP produced comparable overall response rates & survival outcomes with less hematologic & greater gastrointestinal toxicity with IP compared to EP. EP remains the standard of care for ESCLC in North American pts. Population-related differences in pharmacogenomics may explain the divergent results of J9511 & S0124. NIH CA32102

Outcome	IP	EP
Response (CR + PR)	4% + 55% = 59%	1% + 54% = 55%
PFS (months)	5.7*	5.2*
OS (months)	9.7	8.9
% 1 Year Survival	39%	33%
*(p = .03)

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. S0124: A randomized phase III trial comparing irinotecan/cisplatin (IP) with etoposide/cisplatin (EP) in patients (pts) with previously untreated extensive stage small cell lung cancer (E-SCLC)

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

2. S0124: A randomized phase III trial comparing irinotecan/cisplatin (IP) with etoposide/cisplatin (EP) in patients (pts) with previously untreated extensive stage small cell lung cancer (E-SCLC).

Meeting: 2008 ASCO Annual Meeting
Presenter: Ronald B Natale, 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 R. B. Natale :

		1. Concurrent chemotherapy immediately following erlotinib (E) or gefitinib (G) induced apoptosis in previously untreated patients with advanced or metastatic non-small cell lung cancer (NSCLC). Meeting: 2009 ASCO Annual Meeting Abstract No: e19014 First Author: R. B. Natale Category: Lung Cancer--Metastatic Lung Cancer - Metastatic Lung Cancer
		2. Vandetanib versus erlotinib in patients with advanced non-small cell lung cancer (NSCLC) after failure of at least one prior cytotoxic chemotherapy: A randomized, double-blind phase III trial (ZEST). Meeting: 2009 ASCO Annual Meeting Abstract No: 8009 First Author: R. B. Natale Category: Lung Cancer--Metastatic Lung Cancer - Metastatic Lung Cancer
		3. Correlation of quality of pathologic response and surgery with survival for completely resected bladder cancer following neoadjuvant MVAC. Meeting: 2009 Genitourinary Cancers Symposium Abstract No: 249 First Author: G. Sonpavde Category: Genitourinary Cancers - Bladder
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Presentations by R. B. Natale :

		1. Vandetanib versus erlotinib in patients with advanced non-small cell lung cancer (NSCLC) after failure of at least one prior cytotoxic chemotherapy: A randomized, double-blind phase III trial (ZEST). Meeting: 2009 ASCO Annual Meeting Presenter: Ronald B Natale, MD Session: Lung Cancer - Metastatic (Poster Discussion)
		2. S0124: A randomized phase III trial comparing irinotecan/cisplatin (IP) with etoposide/cisplatin (EP) in patients (pts) with previously untreated extensive stage small cell lung cancer (E-SCLC). Meeting: 2008 ASCO Annual Meeting Presenter: Ronald B Natale, MD Session: Lung Cancer — Local-Regional and Adjuvant Therapy (Oral Presentation)
		3. ZD6474 versus gefitinib in patients with advanced NSCLC: Final results from a two-part, double-blind, randomized phase II trial. Meeting: 2006 ASCO Annual Meeting Presenter: Ronald B Natale Session: Angiogenesis Inhibitors in Lung Cancer (Clinical Science Symposium)
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Educational Book Manuscripts by R. B. Natale :

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