Small cell lung cancer - null regimens

The purpose of this page is to provide references to "null therapy" such as placebo and observation. While not clinically relevant, these references provide further insight into the historical development of the treatment landscape. See the main SCLC page for current regimens.

Limited stage, consolidation after upfront therapy

Observation

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Regimen

Study	Years of enrollment	Evidence	Comparator	Comparative Efficacy
Kelly et al. 1995 (SWOG 8812)	1989-1991	Phase III (C)	IFN alfa-2a	Did not meet primary endpoint of OS

No further treatment.

Preceding treatment

• Chemoradiotherapy

References

1. SWOG 8812: Kelly K, Crowley JJ, Bunn PA Jr, Hazuka MB, Beasley K, Upchurch C, Weiss GR, Hicks WJ, Gandara DR, Rivkin S, Livingston R. Role of recombinant interferon alfa-2a maintenance in patients with limited-stage small-cell lung cancer responding to concurrent chemoradiation: a Southwest Oncology Group study. J Clin Oncol. 1995 Dec;13(12):2924-30. link to original article PubMed

Extensive stage, maintenance after first-line therapy

Observation

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Regimen

Study	Years of enrollment	Evidence	Comparator	Comparative Efficacy
Jett et al. 1994 (NCCTG 86-20-51)	1987-1990	Phase III (C)	IFN gamma	Did not meet primary endpoint of OS
van Zandwijk et al. 1997 (EORTC 0883)	1989-1993	Phase III (C)	IFN gamma	Did not meet primary endpoint of OS
Hanna et al. 2002	1993-1998	Phase III (C)	Etoposide	Might have inferior OS
Schiller et al. 2001 (ECOG E7593)	1995-1999	Phase III (C)	Topotecan	Did not meet primary endpoint of OS50%
Ready et al. 2015 (CALGB 30504)	2007-2011	Randomized Phase II (C)	Sunitinib	Seems to have inferior PFS

No further treatment.

Preceding treatment

• ECOG E7593: Cisplatin & Etoposide x 4
• CALGB 30504: Carboplatin & Etoposide or Cisplatin & Etoposide for 4 to 6 cycles

References

1. NCCTG 86-20-51: Jett JR, Maksymiuk AW, Su JQ, Mailliard JA, Krook JE, Tschetter LK, Kardinal CG, Twito DI, Levitt R, Gerstner JB. Phase III trial of recombinant interferon gamma in complete responders with small-cell lung cancer. J Clin Oncol. 1994 Nov;12(11):2321-6. link to original article PubMed
2. EORTC 0883: van Zandwijk N, Groen HJ, Postmus PE, Burghouts JT, ten Velde GP, Ardizzoni A, Smith IE, Baas P, Sahmoud T, Kirkpatrick A, Dalesio O, Giaccone G; EORTC Lung Cancer Cooperative Group. Role of recombinant interferon-gamma maintenance in responding patients with small cell lung cancer: a randomised phase III study of the EORTC Lung Cancer Cooperative Group. Eur J Cancer. 1997 Oct;33(11):1759-66. link to original article PubMed
3. ECOG E7593: Schiller JH, Adak S, Cella D, DeVore RF 3rd, Johnson DH. Topotecan versus observation after cisplatin plus etoposide in extensive-stage small-cell lung cancer: E7593--a phase III trial of the Eastern Cooperative Oncology Group. J Clin Oncol. 2001 Apr 15;19(8):2114-22. link to original article PubMed
4. Hanna NH, Sandier AB, Loehrer PJ Sr, Ansari R, Jung SH, Lane K, Einhorn LH. Maintenance daily oral etoposide versus no further therapy following induction chemotherapy with etoposide plus ifosfamide plus cisplatin in extensive small-cell lung cancer: a Hoosier Oncology Group randomized study. Ann Oncol. 2002 Jan;13(1):95-102. link to original article PubMed
5. CALGB 30504: Ready NE, Pang HH, Gu L, Otterson GA, Thomas SP, Miller AA, Baggstrom M, Masters GA, Graziano SL, Crawford J, Bogart J, Vokes EE. Chemotherapy with or without maintenance sunitinib for untreated extensive-stage small-cell lung cancer: A randomized, double-blind, placebo-controlled phase II study-CALGB 30504 (Alliance). J Clin Oncol. 2015 May 20;33(15):1660-5. Epub 2015 Mar 2. link to original article link to PMC article contains verified protocol PubMed

Placebo

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Regimen

Study	Years of enrollment	Evidence	Comparator	Comparative Efficacy
Shepherd et al. 2002	1997-2000	Phase III (C)	Marimastat	Did not meet primary endpoint of OS

No further antineoplastic treatment.

References

1. Shepherd FA, Giaccone G, Seymour L, Debruyne C, Bezjak A, Hirsh V, Smylie M, Rubin S, Martins H, Lamont A, Krzakowski M, Sadura A, Zee B; NCIC CTG; EORTC. Prospective, randomized, double-blind, placebo-controlled trial of marimastat after response to first-line chemotherapy in patients with small-cell lung cancer: a trial of the National Cancer Institute of Canada-Clinical Trials Group and the European Organisation for Research and Treatment of Cancer. J Clin Oncol. 2002 Nov 15;20(22):4434-9. link to original article PubMed

Relapsed or refractory disease

Best supportive care

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Regimen

Study	Years of enrollment	Evidence	Comparator	Comparative Efficacy
O'Brien et al. 2006	2000-2004	Phase III (C)	Oral topotecan	Seems to have inferior OS

No active antineoplastic treatment.

References

1. O'Brien ME, Ciuleanu TE, Tsekov H, Shparyk Y, Cuceviá B, Juhasz G, Thatcher N, Ross GA, Dane GC, Crofts T. Phase III trial comparing supportive care alone with supportive care with oral topotecan in patients with relapsed small-cell lung cancer. J Clin Oncol. 2006 Dec 1;24(34):5441-7. link to original article contains verified protocol PubMed