Difference between revisions of "Esophageal squamous cell carcinoma - null regimens"
Jump to navigation
Jump to search
Warner-admin (talk | contribs) m (Text replacement - "8 PubMed" to "8/ PubMed") |
m |
||
(13 intermediate revisions by 2 users not shown) | |||
Line 3: | Line 3: | ||
[[#top|Back to Top]] | [[#top|Back to Top]] | ||
</div> | </div> | ||
− | The purpose of this page is to provide references to "null therapy" such as placebo and observation. | + | The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the [[Esophageal squamous cell carcinoma|main esophageal SCC page]] for regimens that include active anticancer treatment. |
{{TOC limit|limit=3}} | {{TOC limit|limit=3}} | ||
Line 20: | Line 20: | ||
|1989-1995 | |1989-1995 | ||
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
− | |[[#Cisplatin_. | + | |[[#Cisplatin_.26_RT_999|Cisplatin & RT]] |
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS60 | | style="background-color:#ffffbf" |Did not meet primary endpoint of OS60 | ||
|- | |- | ||
Line 55: | Line 55: | ||
===References=== | ===References=== | ||
#Bosset JF, Gignoux M, Triboulet JP, Tiret E, Mantion G, Elias D, Lozach P, Ollier JC, Pavy JJ, Mercier M, Sahmoud T. Chemoradiotherapy followed by surgery compared with surgery alone in squamous-cell cancer of the esophagus. N Engl J Med. 1997 Jul 17;337(3):161-7. [https://doi.org/10.1056/NEJM199707173370304 link to original article] [https://pubmed.ncbi.nlm.nih.gov/9219702/ PubMed] | #Bosset JF, Gignoux M, Triboulet JP, Tiret E, Mantion G, Elias D, Lozach P, Ollier JC, Pavy JJ, Mercier M, Sahmoud T. Chemoradiotherapy followed by surgery compared with surgery alone in squamous-cell cancer of the esophagus. N Engl J Med. 1997 Jul 17;337(3):161-7. [https://doi.org/10.1056/NEJM199707173370304 link to original article] [https://pubmed.ncbi.nlm.nih.gov/9219702/ PubMed] | ||
− | #'''CNR-012809:''' Ancona E, Ruol A, Santi S, Merigliano S, Sileni VC, Koussis H, Zaninotto G, Bonavina L, Peracchia A. Only pathologic complete response to neoadjuvant chemotherapy improves significantly the long term survival of patients with resectable esophageal squamous cell carcinoma: final report of a randomized, controlled trial of preoperative chemotherapy versus surgery alone. Cancer. 2001 Jun 1;91(11):2165-74. [https://doi.org/10.1002/1097-0142%2820010601%2991%3A11%3C2165%3A%3AAID-CNCR1245%3E3.0.CO%3B2-H link to original article] | + | #'''CNR-012809:''' Ancona E, Ruol A, Santi S, Merigliano S, Sileni VC, Koussis H, Zaninotto G, Bonavina L, Peracchia A. Only pathologic complete response to neoadjuvant chemotherapy improves significantly the long term survival of patients with resectable esophageal squamous cell carcinoma: final report of a randomized, controlled trial of preoperative chemotherapy versus surgery alone. Cancer. 2001 Jun 1;91(11):2165-74. [https://doi.org/10.1002/1097-0142%2820010601%2991%3A11%3C2165%3A%3AAID-CNCR1245%3E3.0.CO%3B2-H link to original article] [https://pubmed.ncbi.nlm.nih.gov/11391598/ PubMed] [https://clinicaltrials.gov/study/NCT00002897 NCT00002897] |
#Lee JL, Park SI, Kim SB, Jung HY, Lee GH, Kim JH, Song HY, Cho KJ, Kim WK, Lee JS, Kim SH, Min YI. A single institutional phase III trial of preoperative chemotherapy with hyperfractionation radiotherapy plus surgery versus surgery alone for resectable esophageal squamous cell carcinoma. Ann Oncol. 2004 Jun;15(6):947-54. [https://doi.org/10.1093/annonc/mdh219 link to original article] [https://pubmed.ncbi.nlm.nih.gov/15151953/ PubMed] | #Lee JL, Park SI, Kim SB, Jung HY, Lee GH, Kim JH, Song HY, Cho KJ, Kim WK, Lee JS, Kim SH, Min YI. A single institutional phase III trial of preoperative chemotherapy with hyperfractionation radiotherapy plus surgery versus surgery alone for resectable esophageal squamous cell carcinoma. Ann Oncol. 2004 Jun;15(6):947-54. [https://doi.org/10.1093/annonc/mdh219 link to original article] [https://pubmed.ncbi.nlm.nih.gov/15151953/ PubMed] | ||
− | #Boonstra JJ, Kok TC, Wijnhoven BP, van Heijl M, van Berge Henegouwen MI, Ten Kate FJ, Siersema PD, Dinjens WN, van Lanschot JJ, Tilanus HW, van der Gaast A. Chemotherapy followed by surgery versus surgery alone in patients with resectable oesophageal squamous cell carcinoma: long-term results of a randomized controlled trial. BMC Cancer. 2011 May 19;11:181. [https://doi.org/10.1186/1471-2407-11-181 link to original article] | + | #Boonstra JJ, Kok TC, Wijnhoven BP, van Heijl M, van Berge Henegouwen MI, Ten Kate FJ, Siersema PD, Dinjens WN, van Lanschot JJ, Tilanus HW, van der Gaast A. Chemotherapy followed by surgery versus surgery alone in patients with resectable oesophageal squamous cell carcinoma: long-term results of a randomized controlled trial. BMC Cancer. 2011 May 19;11:181. [https://doi.org/10.1186/1471-2407-11-181 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3123658/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/21595951/ PubMed] |
− | #'''NEOCRTEC5010:''' Yang H, Liu H, Chen Y, Zhu C, Fang W, Yu Z, Mao W, Xiang J, Han Y, Chen Z, Yang H, Wang J, Pang Q, Zheng X, Yang H, Li T, Lordick F, D'Journo XB, Cerfolio RJ, Korst RJ, Novoa NM, Swanson SJ, Brunelli A, Ismail M, Fernando HC, Zhang X, Li Q, Wang G, Chen B, Mao T, Kong M, Guo X, Lin T, Liu M, Fu J; AME Thoracic Surgery Collaborative Group. Neoadjuvant chemoradiotherapy followed by surgery versus surgery alone for locally advanced squamous cell carcinoma of the esophagus (NEOCRTEC5010): a phase III multicenter, randomized, open-label clinical trial. J Clin Oncol. 2018 Sep 20;36(27):2796-2803. Epub 2018 Aug 8. [https://doi.org/10.1200/JCO.2018.79.1483 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6145832/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/30089078/ PubMed] NCT01216527 | + | #'''NEOCRTEC5010:''' Yang H, Liu H, Chen Y, Zhu C, Fang W, Yu Z, Mao W, Xiang J, Han Y, Chen Z, Yang H, Wang J, Pang Q, Zheng X, Yang H, Li T, Lordick F, D'Journo XB, Cerfolio RJ, Korst RJ, Novoa NM, Swanson SJ, Brunelli A, Ismail M, Fernando HC, Zhang X, Li Q, Wang G, Chen B, Mao T, Kong M, Guo X, Lin T, Liu M, Fu J; AME Thoracic Surgery Collaborative Group. Neoadjuvant chemoradiotherapy followed by surgery versus surgery alone for locally advanced squamous cell carcinoma of the esophagus (NEOCRTEC5010): a phase III multicenter, randomized, open-label clinical trial. J Clin Oncol. 2018 Sep 20;36(27):2796-2803. Epub 2018 Aug 8. [https://doi.org/10.1200/JCO.2018.79.1483 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6145832/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/30089078/ PubMed] [https://clinicaltrials.gov/study/NCT01216527 NCT01216527] |
##'''Update:''' Yang H, Liu H, Chen Y, Zhu C, Fang W, Yu Z, Mao W, Xiang J, Han Y, Chen Z, Yang H, Wang J, Pang Q, Zheng X, Yang H, Li T, Zhang X, Li Q, Wang G, Chen B, Mao T, Kong M, Guo X, Lin T, Liu M, Fu J. Long-term Efficacy of Neoadjuvant Chemoradiotherapy Plus Surgery for the Treatment of Locally Advanced Esophageal Squamous Cell Carcinoma: The NEOCRTEC5010 Randomized Clinical Trial. JAMA Surg. 2021 Aug 1;156(8):721-729. [https://doi.org/10.1001/jamasurg.2021.2373 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8223138/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/34160577/ PubMed] | ##'''Update:''' Yang H, Liu H, Chen Y, Zhu C, Fang W, Yu Z, Mao W, Xiang J, Han Y, Chen Z, Yang H, Wang J, Pang Q, Zheng X, Yang H, Li T, Zhang X, Li Q, Wang G, Chen B, Mao T, Kong M, Guo X, Lin T, Liu M, Fu J. Long-term Efficacy of Neoadjuvant Chemoradiotherapy Plus Surgery for the Treatment of Locally Advanced Esophageal Squamous Cell Carcinoma: The NEOCRTEC5010 Randomized Clinical Trial. JAMA Surg. 2021 Aug 1;156(8):721-729. [https://doi.org/10.1001/jamasurg.2021.2373 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8223138/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/34160577/ PubMed] | ||
=Adjuvant therapy= | =Adjuvant therapy= | ||
Line 74: | Line 74: | ||
|1988-1991 | |1988-1991 | ||
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
− | |[[#Cisplatin_. | + | |[[#Cisplatin_.26_Vindesine_999|Cisplatin & Vindesine]] |
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS60 | | style="background-color:#ffffbf" |Did not meet primary endpoint of OS60 | ||
|- | |- | ||
Line 94: | Line 94: | ||
#'''JCOG8806:''' Ando N, Iizuka T, Kakegawa T, Isono K, Watanabe H, Ide H, Tanaka O, Shinoda M, Takiyama W, Arimori M, Ishida K, Tsugane S. A randomized trial of surgery with and without chemotherapy for localized squamous carcinoma of the thoracic esophagus: the Japan Clinical Oncology Group Study. J Thorac Cardiovasc Surg. 1997 Aug;114(2):205-9. [https://doi.org/10.1016/S0022-5223(97)70146-6 link to original article] [https://pubmed.ncbi.nlm.nih.gov/9270637/ PubMed] | #'''JCOG8806:''' Ando N, Iizuka T, Kakegawa T, Isono K, Watanabe H, Ide H, Tanaka O, Shinoda M, Takiyama W, Arimori M, Ishida K, Tsugane S. A randomized trial of surgery with and without chemotherapy for localized squamous carcinoma of the thoracic esophagus: the Japan Clinical Oncology Group Study. J Thorac Cardiovasc Surg. 1997 Aug;114(2):205-9. [https://doi.org/10.1016/S0022-5223(97)70146-6 link to original article] [https://pubmed.ncbi.nlm.nih.gov/9270637/ PubMed] | ||
− | #'''JCOG 9204:''' Ando N, Iizuka T, Ide H, Ishida K, Shinoda M, Nishimaki T, Takiyama W, Watanabe H, Isono K, Aoyama N, Makuuchi H, Tanaka O, Yamana H, Ikeuchi S, Kabuto T, Nagai K, Shimada Y, Kinjo Y, Fukuda H; [[Study_Groups#JCOG|JCOG]]. Surgery plus chemotherapy compared with surgery alone for localized squamous cell carcinoma of the thoracic esophagus: a Japan Clinical Oncology Group Study--JCOG9204. J Clin Oncol. 2003 Dec 15;21(24):4592-6. [https://doi.org/10.1200/JCO.2003.12.095 link to original article] | + | #'''JCOG 9204:''' Ando N, Iizuka T, Ide H, Ishida K, Shinoda M, Nishimaki T, Takiyama W, Watanabe H, Isono K, Aoyama N, Makuuchi H, Tanaka O, Yamana H, Ikeuchi S, Kabuto T, Nagai K, Shimada Y, Kinjo Y, Fukuda H; [[Study_Groups#JCOG|JCOG]]. Surgery plus chemotherapy compared with surgery alone for localized squamous cell carcinoma of the thoracic esophagus: a Japan Clinical Oncology Group Study--JCOG9204. J Clin Oncol. 2003 Dec 15;21(24):4592-6. [https://doi.org/10.1200/JCO.2003.12.095 link to original article] [https://pubmed.ncbi.nlm.nih.gov/14673047/ PubMed] |
=Consolidation after definitive therapy= | =Consolidation after definitive therapy= | ||
Line 107: | Line 107: | ||
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
|- | |- | ||
− | |[https://clinicaltrials.gov/ | + | |[https://clinicaltrials.gov/study/NCT04543617 Awaiting publication (SKYSCRAPER-07)] |
|2020-2024 | |2020-2024 | ||
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
− | |1. [[# | + | |1. [[#Atezolizumab_monotherapy_666|Atezolizumab]]<br>2. [[#Atezolizumab_.26_Tiragolumab_777|Atezolizumab & Tiragolumab]] |
− | | style="background-color:#d3d3d3" | | + | | style="background-color:#d3d3d3" |TBD if different primary endpoints of PFS/OS |
|- | |- | ||
|} | |} | ||
Line 121: | Line 121: | ||
</div></div> | </div></div> | ||
===References=== | ===References=== | ||
− | #'''SKYSCRAPER-07:''' NCT04543617 | + | #'''SKYSCRAPER-07:''' [https://clinicaltrials.gov/study/NCT04543617 NCT04543617] |
[[Category:Esophageal cancer regimens]] | [[Category:Esophageal cancer regimens]] | ||
[[Category:Null regimens]] | [[Category:Null regimens]] | ||
− | [[Category: | + | [[Category:Histology-specific pages]] |
[[Category:Gastroesophageal cancers]] | [[Category:Gastroesophageal cancers]] |
Latest revision as of 02:02, 6 March 2024
The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the main esophageal SCC page for regimens that include active anticancer treatment.
Neoadjuvant induction therapy
No neoadjuvant therapy
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Bosset et al. 1997 | 1989-1995 | Phase 3 (C) | Cisplatin & RT | Did not meet primary endpoint of OS60 |
Boonstra et al. 2011 | 1989-1996 | Phase 3 (C) | EP | Seems to have inferior OS |
Ancona et al. 2001 (CNR-012809) | 1992-1997 | Phase 3 (C) | CF | Did not meet primary endpoint of OS |
Lee et al. 2004 | 1999-2002 | Phase 3 (C) | CF & RT | Did not meet primary endpoint of OS50% |
Yang et al. 2018 (NEOCRTEC5010) | 2007-2014 | Phase 3 (C) | Cisplatin, Vinorelbine, RT | Seems to have inferior OS |
Surgery as primary therapy; i.e., no induction chemotherapy or chemoradiotherapy, and no adjuvant therapy.
Subsequent treatment
References
- Bosset JF, Gignoux M, Triboulet JP, Tiret E, Mantion G, Elias D, Lozach P, Ollier JC, Pavy JJ, Mercier M, Sahmoud T. Chemoradiotherapy followed by surgery compared with surgery alone in squamous-cell cancer of the esophagus. N Engl J Med. 1997 Jul 17;337(3):161-7. link to original article PubMed
- CNR-012809: Ancona E, Ruol A, Santi S, Merigliano S, Sileni VC, Koussis H, Zaninotto G, Bonavina L, Peracchia A. Only pathologic complete response to neoadjuvant chemotherapy improves significantly the long term survival of patients with resectable esophageal squamous cell carcinoma: final report of a randomized, controlled trial of preoperative chemotherapy versus surgery alone. Cancer. 2001 Jun 1;91(11):2165-74. link to original article PubMed NCT00002897
- Lee JL, Park SI, Kim SB, Jung HY, Lee GH, Kim JH, Song HY, Cho KJ, Kim WK, Lee JS, Kim SH, Min YI. A single institutional phase III trial of preoperative chemotherapy with hyperfractionation radiotherapy plus surgery versus surgery alone for resectable esophageal squamous cell carcinoma. Ann Oncol. 2004 Jun;15(6):947-54. link to original article PubMed
- Boonstra JJ, Kok TC, Wijnhoven BP, van Heijl M, van Berge Henegouwen MI, Ten Kate FJ, Siersema PD, Dinjens WN, van Lanschot JJ, Tilanus HW, van der Gaast A. Chemotherapy followed by surgery versus surgery alone in patients with resectable oesophageal squamous cell carcinoma: long-term results of a randomized controlled trial. BMC Cancer. 2011 May 19;11:181. link to original article link to PMC article PubMed
- NEOCRTEC5010: Yang H, Liu H, Chen Y, Zhu C, Fang W, Yu Z, Mao W, Xiang J, Han Y, Chen Z, Yang H, Wang J, Pang Q, Zheng X, Yang H, Li T, Lordick F, D'Journo XB, Cerfolio RJ, Korst RJ, Novoa NM, Swanson SJ, Brunelli A, Ismail M, Fernando HC, Zhang X, Li Q, Wang G, Chen B, Mao T, Kong M, Guo X, Lin T, Liu M, Fu J; AME Thoracic Surgery Collaborative Group. Neoadjuvant chemoradiotherapy followed by surgery versus surgery alone for locally advanced squamous cell carcinoma of the esophagus (NEOCRTEC5010): a phase III multicenter, randomized, open-label clinical trial. J Clin Oncol. 2018 Sep 20;36(27):2796-2803. Epub 2018 Aug 8. link to original article link to PMC article PubMed NCT01216527
- Update: Yang H, Liu H, Chen Y, Zhu C, Fang W, Yu Z, Mao W, Xiang J, Han Y, Chen Z, Yang H, Wang J, Pang Q, Zheng X, Yang H, Li T, Zhang X, Li Q, Wang G, Chen B, Mao T, Kong M, Guo X, Lin T, Liu M, Fu J. Long-term Efficacy of Neoadjuvant Chemoradiotherapy Plus Surgery for the Treatment of Locally Advanced Esophageal Squamous Cell Carcinoma: The NEOCRTEC5010 Randomized Clinical Trial. JAMA Surg. 2021 Aug 1;156(8):721-729. link to original article link to PMC article PubMed
Adjuvant therapy
Observation
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Ando et al. 1997 (JCOG8806) | 1988-1991 | Phase 3 (C) | Cisplatin & Vindesine | Did not meet primary endpoint of OS60 |
Ando et al. 2003 (JCOG 9204) | 1992-1997 | Phase 3 (C) | CF | Seems to have inferior DFS |
Surgery as primary therapy; i.e., no induction chemotherapy or chemoradiotherapy, and no adjuvant therapy.
Preceding treatment
References
- JCOG8806: Ando N, Iizuka T, Kakegawa T, Isono K, Watanabe H, Ide H, Tanaka O, Shinoda M, Takiyama W, Arimori M, Ishida K, Tsugane S. A randomized trial of surgery with and without chemotherapy for localized squamous carcinoma of the thoracic esophagus: the Japan Clinical Oncology Group Study. J Thorac Cardiovasc Surg. 1997 Aug;114(2):205-9. link to original article PubMed
- JCOG 9204: Ando N, Iizuka T, Ide H, Ishida K, Shinoda M, Nishimaki T, Takiyama W, Watanabe H, Isono K, Aoyama N, Makuuchi H, Tanaka O, Yamana H, Ikeuchi S, Kabuto T, Nagai K, Shimada Y, Kinjo Y, Fukuda H; JCOG. Surgery plus chemotherapy compared with surgery alone for localized squamous cell carcinoma of the thoracic esophagus: a Japan Clinical Oncology Group Study--JCOG9204. J Clin Oncol. 2003 Dec 15;21(24):4592-6. link to original article PubMed
Consolidation after definitive therapy
Placebo
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Awaiting publication (SKYSCRAPER-07) | 2020-2024 | Phase 3 (C) | 1. Atezolizumab 2. Atezolizumab & Tiragolumab |
TBD if different primary endpoints of PFS/OS |
No active antineoplastic treatment.
Preceding treatment
- Definitive chemoradiotherapy (not specified)
References
- SKYSCRAPER-07: NCT04543617