Difference between revisions of "Small cell lung cancer - null regimens"
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===Regimen=== | ===Regimen=== | ||
{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
| − | ! style="width: | + | !style="width: 20%"|Study |
| − | ! style="width: | + | !style="width: 20%"|Years of enrollment |
| − | ! style="width: | + | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] |
| − | ! style="width: | + | !style="width: 20%"|Comparator |
| + | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
|- | |- | ||
| − | |[https://ascopubs.org/doi/abs/10.1200/JCO.1995.13.12.2924 Kelly et al. 1995] | + | |[https://ascopubs.org/doi/abs/10.1200/JCO.1995.13.12.2924 Kelly et al. 1995 (SWOG 8812)] |
| + | |1989-1991 | ||
| style="background-color:#1a9851" |Phase III (C) | | style="background-color:#1a9851" |Phase III (C) | ||
|IFN alfa-2a | |IFN alfa-2a | ||
| Line 25: | Line 27: | ||
*Chemoradiotherapy | *Chemoradiotherapy | ||
===References=== | ===References=== | ||
| − | # 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. [https://ascopubs.org/doi/abs/10.1200/JCO.1995.13.12.2924 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/8523056 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. [https://ascopubs.org/doi/abs/10.1200/JCO.1995.13.12.2924 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/8523056 PubMed] |
=Extensive stage, maintenance after first-line therapy= | =Extensive stage, maintenance after first-line therapy= | ||
| Line 35: | Line 37: | ||
===Regimen=== | ===Regimen=== | ||
{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
| − | ! style="width: | + | !style="width: 20%"|Study |
| − | ! style="width: | + | !style="width: 20%"|Years of enrollment |
| − | ! style="width: | + | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] |
| − | ! style="width: | + | !style="width: 20%"|Comparator |
| + | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
|- | |- | ||
| − | |[https://ascopubs.org/doi/abs/10.1200/JCO.1994.12.11.2321 Jett et al. 1994] | + | |[https://ascopubs.org/doi/abs/10.1200/JCO.1994.12.11.2321 Jett et al. 1994 (NCCTG 86-20-51)] |
| + | |1987-1990 | ||
| style="background-color:#1a9851" |Phase III (C) | | style="background-color:#1a9851" |Phase III (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 | ||
|- | |- | ||
| − | |[https://www.ejcancer.com/article/S0959-8049(97)00174-3/pdf van Zandwijk et al. 1997] | + | |[https://www.ejcancer.com/article/S0959-8049(97)00174-3/pdf van Zandwijk et al. 1997 (EORTC 0883)] |
| + | |1989-1993 | ||
| style="background-color:#1a9851" |Phase III (C) | | style="background-color:#1a9851" |Phase III (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 | ||
| + | |- | ||
| + | |[https://doi.org/10.1093/annonc/mdf014 Hanna et al. 2002] | ||
| + | |1993-1998 | ||
| + | | style="background-color:#1a9851" |Phase III (C) | ||
| + | |Etoposide | ||
| + | | style="background-color:#fee08b" |Might have inferior OS | ||
|- | |- | ||
|[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 | ||
| style="background-color:#1a9851" |Phase III (C) | | style="background-color:#1a9851" |Phase III (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% | ||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
|- | |- | ||
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4429175/ Ready et al. 2015 (CALGB 30504)] | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4429175/ Ready et al. 2015 (CALGB 30504)] | ||
| + | |2007-2011 | ||
| style="background-color:#1a9851" |Randomized Phase II (C) | | style="background-color:#1a9851" |Randomized Phase II (C) | ||
|[[Small_cell_lung_cancer#Sunitinib_monotherapy|Sunitinib]] | |[[Small_cell_lung_cancer#Sunitinib_monotherapy|Sunitinib]] | ||
| Line 72: | Line 80: | ||
===References=== | ===References=== | ||
| − | # 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. [https://ascopubs.org/doi/abs/10.1200/JCO.1994.12.11.2321 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/7964947 PubMed] | + | # '''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. [https://ascopubs.org/doi/abs/10.1200/JCO.1994.12.11.2321 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/7964947 PubMed] |
| − | # 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. 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. [https://www.ejcancer.com/article/S0959-8049(97)00174-3/pdf link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/9470829 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. [https://www.ejcancer.com/article/S0959-8049(97)00174-3/pdf link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/9470829 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. [https://doi.org/10.1200/JCO.2001.19.8.2114 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/11304763 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. [https://doi.org/10.1200/JCO.2001.19.8.2114 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/11304763 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. [https:// | + | # 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. [https://doi.org/10.1093/annonc/mdf014 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/11863118 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. [https://doi.org/10.1200/JCO.2014.57.3105 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4429175/ link to PMC article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/25732163 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. [https://doi.org/10.1200/JCO.2014.57.3105 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4429175/ link to PMC article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/25732163 PubMed] | ||
| Line 85: | Line 93: | ||
===Regimen=== | ===Regimen=== | ||
{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
| − | ! style="width: | + | !style="width: 20%"|Study |
| − | ! style="width: | + | !style="width: 20%"|Years of enrollment |
| − | ! style="width: | + | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] |
| − | ! style="width: | + | !style="width: 20%"|Comparator |
| + | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
|- | |- | ||
|[https://doi.org/10.1200/JCO.2002.02.108 Shepherd et al. 2002] | |[https://doi.org/10.1200/JCO.2002.02.108 Shepherd et al. 2002] | ||
| + | |1997-2000 | ||
| style="background-color:#1a9851" |Phase III (C) | | style="background-color:#1a9851" |Phase III (C) | ||
|Marimastat | |Marimastat | ||
| Line 98: | Line 108: | ||
''No further antineoplastic treatment.'' | ''No further antineoplastic treatment.'' | ||
===References=== | ===References=== | ||
| − | # 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. 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 Organization for Research and Treatment of Cancer. J Clin Oncol. 2002 Nov 15;20(22):4434-9. [https://doi.org/10.1200/JCO.2002.02.108 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/12431965 PubMed] | + | # 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 Organization for Research and Treatment of Cancer. J Clin Oncol. 2002 Nov 15;20(22):4434-9. [https://doi.org/10.1200/JCO.2002.02.108 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/12431965 PubMed] |
=Relapsed or refractory disease= | =Relapsed or refractory disease= | ||
| Line 109: | Line 119: | ||
===Regimen=== | ===Regimen=== | ||
{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
| − | ! style="width: | + | !style="width: 20%"|Study |
| − | ! style="width: | + | !style="width: 20%"|Years of enrollment |
| − | ! style="width: | + | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] |
| − | ! style="width: | + | !style="width: 20%"|Comparator |
| + | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
|- | |- | ||
|[http://jco.ascopubs.org/content/24/34/5441.long O'Brien et al. 2006] | |[http://jco.ascopubs.org/content/24/34/5441.long O'Brien et al. 2006] | ||
| + | |2000-2004 | ||
| style="background-color:#1a9851" |Phase III (C) | | style="background-color:#1a9851" |Phase III (C) | ||
|[[Small_cell_lung_cancer#Topotecan_monotherapy|Oral topotecan]] | |[[Small_cell_lung_cancer#Topotecan_monotherapy|Oral topotecan]] | ||
Revision as of 14:52, 8 March 2020
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
| back to top |
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
- 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
| back to top |
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
- 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
Placebo
| back to top |
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
- 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 Organization 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
| back to top |
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
- 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