Difference between revisions of "Small cell lung cancer - null regimens"
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m (Text replacement - "style="background-color:#1a9851" |Phase III" to "style="background-color:#1a9851" |Phase 3") |
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|[https://doi.org/10.1200/jco.1994.12.11.2321 Jett et al. 1994 (NCCTG 86-20-51)] | |[https://doi.org/10.1200/jco.1994.12.11.2321 Jett et al. 1994 (NCCTG 86-20-51)] | ||
|1987-1990 | |1987-1990 | ||
| − | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (C) |
|IFN gamma | |IFN gamma | ||
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS | | style="background-color:#ffffbf" |Did not meet primary endpoint of OS | ||
| Line 24: | Line 24: | ||
|[https://doi.org/10.1200/JCO.1995.13.12.2924 Kelly et al. 1995 (SWOG 8812)] | |[https://doi.org/10.1200/JCO.1995.13.12.2924 Kelly et al. 1995 (SWOG 8812)] | ||
|1989-1991 | |1989-1991 | ||
| − | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (C) |
|IFN alfa-2a | |IFN alfa-2a | ||
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS | | style="background-color:#ffffbf" |Did not meet primary endpoint of OS | ||
| Line 30: | Line 30: | ||
|[https://doi.org/10.1200/jco.2005.17.186 Giaccone et al. 2005 (Silva)] | |[https://doi.org/10.1200/jco.2005.17.186 Giaccone et al. 2005 (Silva)] | ||
|1998-2002 | |1998-2002 | ||
| − | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (C) |
|Bec2 & BCG | |Bec2 & BCG | ||
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS | | style="background-color:#ffffbf" |Did not meet primary endpoint of OS | ||
| Line 58: | Line 58: | ||
|(ADRIATIC) | |(ADRIATIC) | ||
|2018-ongoing | |2018-ongoing | ||
| − | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (C) |
|1. Durvalumab<br> 2. Durvalumab & Tremelimumab | |1. Durvalumab<br> 2. Durvalumab & Tremelimumab | ||
| style="background-color:#d3d3d3" |In progress | | style="background-color:#d3d3d3" |In progress | ||
| Line 64: | Line 64: | ||
|(KEYLYNK-013) | |(KEYLYNK-013) | ||
|2020-ongoing | |2020-ongoing | ||
| − | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (C) |
|1. Pembrolizumab<br> 2. Olaparib & Pembrolizumab | |1. Pembrolizumab<br> 2. Olaparib & Pembrolizumab | ||
| style="background-color:#d3d3d3" |In progress | | style="background-color:#d3d3d3" |In progress | ||
| Line 90: | Line 90: | ||
|[https://doi.org/10.1200/JCO.1994.12.11.2321 Jett et al. 1994 (NCCTG 86-20-51)] | |[https://doi.org/10.1200/JCO.1994.12.11.2321 Jett et al. 1994 (NCCTG 86-20-51)] | ||
|1987-1990 | |1987-1990 | ||
| − | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (C) |
|IFN gamma | |IFN gamma | ||
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS | | style="background-color:#ffffbf" |Did not meet primary endpoint of OS | ||
| Line 96: | Line 96: | ||
|[https://doi.org/10.1016/s0959-8049(97)00174-3 van Zandwijk et al. 1997 (EORTC 0883)] | |[https://doi.org/10.1016/s0959-8049(97)00174-3 van Zandwijk et al. 1997 (EORTC 0883)] | ||
|1989-1993 | |1989-1993 | ||
| − | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (C) |
|IFN gamma | |IFN gamma | ||
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS | | style="background-color:#ffffbf" |Did not meet primary endpoint of OS | ||
| Line 102: | Line 102: | ||
|[https://doi.org/10.1093/annonc/mdf014 Hanna et al. 2002] | |[https://doi.org/10.1093/annonc/mdf014 Hanna et al. 2002] | ||
|1993-1998 | |1993-1998 | ||
| − | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (C) |
|Etoposide | |Etoposide | ||
| style="background-color:#fee08b" |Might have inferior OS | | style="background-color:#fee08b" |Might have inferior OS | ||
| Line 108: | Line 108: | ||
|[https://doi.org/10.1200/JCO.2001.19.8.2114 Schiller et al. 2001 (ECOG E7593)] | |[https://doi.org/10.1200/JCO.2001.19.8.2114 Schiller et al. 2001 (ECOG E7593)] | ||
|1995-1999 | |1995-1999 | ||
| − | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (C) |
|Topotecan | |Topotecan | ||
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS50% | | style="background-color:#ffffbf" |Did not meet primary endpoint of OS50% | ||
| Line 120: | Line 120: | ||
|[https://doi.org/10.1016/j.lungcan.2019.06.011 Santo et al. 2019 (G04.2011)] | |[https://doi.org/10.1016/j.lungcan.2019.06.011 Santo et al. 2019 (G04.2011)] | ||
|2012-2016 | |2012-2016 | ||
| − | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (C) |
|Lanreotide | |Lanreotide | ||
| style="background-color:#ffffbf" |Did not meet primary endpoint of PFS | | style="background-color:#ffffbf" |Did not meet primary endpoint of PFS | ||
| Line 156: | Line 156: | ||
|[https://doi.org/10.1200/JCO.2002.02.108 Shepherd et al. 2002 (NCIC-CTG BR.12)] | |[https://doi.org/10.1200/JCO.2002.02.108 Shepherd et al. 2002 (NCIC-CTG BR.12)] | ||
|1997-2000 | |1997-2000 | ||
| − | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (C) |
|Marimastat | |Marimastat | ||
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS | | style="background-color:#ffffbf" |Did not meet primary endpoint of OS | ||
| Line 162: | Line 162: | ||
|[https://doi.org/10.1200/jco.20.02212 Owonikoko et al. 2021 (CheckMate 451)] | |[https://doi.org/10.1200/jco.20.02212 Owonikoko et al. 2021 (CheckMate 451)] | ||
|2015-2018 | |2015-2018 | ||
| − | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (C) |
|1. Ipilimumab & Nivolumab<br> 2. Nivolumab | |1. Ipilimumab & Nivolumab<br> 2. Nivolumab | ||
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS | | style="background-color:#ffffbf" |Did not meet primary endpoint of OS | ||
| Line 168: | Line 168: | ||
|[https://doi.org/10.1016/j.jtho.2021.04.001 Ai et al. 2021 (ZL-2306-005)] | |[https://doi.org/10.1016/j.jtho.2021.04.001 Ai et al. 2021 (ZL-2306-005)] | ||
|2018-2020 | |2018-2020 | ||
| − | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (C) |
|Niraparib | |Niraparib | ||
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS | | style="background-color:#ffffbf" |Did not meet primary endpoint of OS | ||
| Line 199: | Line 199: | ||
|[https://doi.org/10.1200/jco.2006.06.5821 O'Brien et al. 2006 (GSK 104864/478)] | |[https://doi.org/10.1200/jco.2006.06.5821 O'Brien et al. 2006 (GSK 104864/478)] | ||
|2000-2004 | |2000-2004 | ||
| − | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (C) |
|[[Small_cell_lung_cancer#Topotecan_monotherapy|Oral topotecan]] | |[[Small_cell_lung_cancer#Topotecan_monotherapy|Oral topotecan]] | ||
| style="background-color:#fc8d59" |Seems to have inferior OS | | style="background-color:#fc8d59" |Seems to have inferior OS | ||
Revision as of 02:35, 16 December 2021
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 |
|---|---|---|---|---|
| Jett et al. 1994 (NCCTG 86-20-51) | 1987-1990 | Phase 3 (C) | IFN gamma | Did not meet primary endpoint of OS |
| Kelly et al. 1995 (SWOG 8812) | 1989-1991 | Phase 3 (C) | IFN alfa-2a | Did not meet primary endpoint of OS |
| Giaccone et al. 2005 (Silva) | 1998-2002 | Phase 3 (C) | Bec2 & BCG | Did not meet primary endpoint of OS |
No further treatment.
Preceding treatment
- Chemoradiotherapy
References
- 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
- 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
- Silva: Giaccone G, Debruyne C, Felip E, Chapman PB, Grant SC, Millward M, Thiberville L, D'addario G, Coens C, Rome LS, Zatloukal P, Masso O, Legrand C; EORTC. Phase III study of adjuvant vaccination with Bec2/bacille Calmette-Guerin in responding patients with limited-disease small-cell lung cancer (European Organisation for Research and Treatment of Cancer 08971-08971B; Silva Study). J Clin Oncol. 2005 Oct 1;23(28):6854-64. link to original article PubMed NCT00037713
Placebo
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Regimen
| Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| (ADRIATIC) | 2018-ongoing | Phase 3 (C) | 1. Durvalumab 2. Durvalumab & Tremelimumab |
In progress |
| (KEYLYNK-013) | 2020-ongoing | Phase 3 (C) | 1. Pembrolizumab 2. Olaparib & Pembrolizumab |
In progress |
No further antineoplastic treatment.
References
- ADRIATIC: NCT03703297
- KEYLYNK-013: NCT04624204
Extensive stage, maintenance after first-line therapy
Observation
| back to top |
Regimen
| Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Jett et al. 1994 (NCCTG 86-20-51) | 1987-1990 | Phase 3 (C) | IFN gamma | Did not meet primary endpoint of OS |
| van Zandwijk et al. 1997 (EORTC 0883) | 1989-1993 | Phase 3 (C) | IFN gamma | Did not meet primary endpoint of OS |
| Hanna et al. 2002 | 1993-1998 | Phase 3 (C) | Etoposide | Might have inferior OS |
| Schiller et al. 2001 (ECOG E7593) | 1995-1999 | Phase 3 (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 |
| Santo et al. 2019 (G04.2011) | 2012-2016 | Phase 3 (C) | Lanreotide | Did not meet primary endpoint of PFS |
No further treatment.
Biomarker eligibility criteria
- G04.2011: Somatostatin receptor positivity at diagnosis
Preceding treatment
- ECOG E7593: Cisplatin & Etoposide x 4
- CALGB 30504: Carboplatin & Etoposide or Cisplatin & Etoposide for 4 to 6 cycles
- G04.2011: Carboplatin & Etoposide or Cisplatin & Etoposide
References
- 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
- 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
- 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
- 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
- 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 NCT00453154
- G04.2011: Santo A, Pilotto S, Galetta D, Grossi F, Fasola G, Romano G, Bonanno L, Bearz A, Papi M, Roca E, Catino A, Follador A, Rijavec E, Genova C, Petrillo P, Favaretto A, Giannone L, Milella M, Tortora G, Giannarelli D, Bria E; Italian association FONICAP (Operative National Interdisciplinary Force against Lung Cancer). Maintenance with lanreotide in small-cell lung cancer expressing somatostatine receptors: A multicenter, randomized, phase 3 trial. Lung Cancer. 2019 Aug;134:121-126. Epub 2019 Jun 11. link to original article PubMed EudraCT 2011-005730-20
Placebo
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Regimen
| Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Shepherd et al. 2002 (NCIC-CTG BR.12) | 1997-2000 | Phase 3 (C) | Marimastat | Did not meet primary endpoint of OS |
| Owonikoko et al. 2021 (CheckMate 451) | 2015-2018 | Phase 3 (C) | 1. Ipilimumab & Nivolumab 2. Nivolumab |
Did not meet primary endpoint of OS |
| Ai et al. 2021 (ZL-2306-005) | 2018-2020 | Phase 3 (C) | Niraparib | Did not meet primary endpoint of OS |
No further antineoplastic treatment.
Preceding treatment
- NCIC-CTG BR.12: First-line combination chemotherapy x 4, with PR/CR
- CheckMate 451: Platinum-based chemotherapy x 3 to 4
References
- NCIC-CTG BR.12: 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 NCT00003011
- CheckMate 451: Owonikoko TK, Park K, Govindan R, Ready N, Reck M, Peters S, Dakhil SR, Navarro A, Rodríguez-Cid J, Schenker M, Lee JS, Gutierrez V, Percent I, Morgensztern D, Barrios CH, Greillier L, Baka S, Patel M, Lin WH, Selvaggi G, Baudelet C, Baden J, Pandya D, Doshi P, Kim HR. Nivolumab and Ipilimumab as Maintenance Therapy in Extensive-Disease Small-Cell Lung Cancer: CheckMate 451. J Clin Oncol. 2021 Apr 20;39(12):1349-1359. Epub 2021 Mar 8. link to original article PubMed NCT02538666
- ZL-2306-005: Ai X, Pan Y, Shi J, Yang N, Liu C, Zhou J, Zhang X, Dong X, He J, Li X, Chen G, Li X, Zhang H, Liao W, Zhang Y, Ma Z, Jiang L, Cui J, Hu C, Wang W, Huang C, Zhao J, Ding C, Hu X, Wang K, Gao B, Song Y, Liu X, Xiong J, Liu A, Li J, Liu Z, Li Y, Wang M, Zhang B, Zhang D, Lu S. Efficacy and Safety of Niraparib as Maintenance Treatment in Patients With Extensive-Stage SCLC After First-Line Chemotherapy: A Randomized, Double-Blind, Phase 3 Study. J Thorac Oncol. 2021 Aug;16(8):1403-1414. Epub 2021 Apr 26. link to original article PubMed NCT03516084
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 (GSK 104864/478) | 2000-2004 | Phase 3 (C) | Oral topotecan | Seems to have inferior OS |
No active antineoplastic treatment.
References
- GSK 104864/478: 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 PubMed NCT00276276