Neoadjuvant Chemotherapy, Excision, and Observation for Early Rectal Cancer : The Phase II NEO Trial (CCTG CO.28) Primary End Point Results
PURPOSE: Organ-sparing therapy for early-stage I/IIA rectal cancer is intended to avoid functional disturbances or a permanent ostomy associated with total mesorectal excision (TME). The objective of this phase II trial was to determine the outcomes and organ-sparing rate of patients with early-stage rectal cancer treated with neoadjuvant chemotherapy followed by transanal excision surgery (TES).
METHODS: This phase II trial included patients with clinical T1-T3abN0 low- or mid-rectal adenocarcinoma eligible for endoscopic resection who were treated with 3 months of chemotherapy (modified folinic acid-fluorouracil-oxaliplatin 6 or capecitabine-oxaliplatin). Those with evidence of response proceeded to transanal endoscopic surgery 2-6 weeks later. The primary end point was protocol-specified organ preservation rate, defined as the proportion of patients with tumor downstaging to ypT0/T1N0/X and who avoided radical surgery.
RESULTS: Of 58 patients enrolled, all commenced chemotherapy and 56 proceeded to surgery. A total of 33/58 patients had tumor downstaging to ypT0/1N0/X on the surgery specimen, resulting in an intention-to-treat protocol-specified organ preservation rate of 57% (90% CI, 45 to 68). Of 23 remaining patients recommended for TME surgery on the basis of protocol requirements, 13 declined and elected to proceed directly to observation resulting in 79% (90% CI, 69 to 88) achieving organ preservation. The remaining 10/23 patients proceeded to recommended TME of whom seven had no histopathologic residual disease. The 1-year and 2-year locoregional relapse-free survival was, respectively, 98% (95% CI, 86 to 100) and 90% (95% CI, 58 to 98), and there were no distant recurrences or deaths. Minimal change in quality of life and rectal function scores was observed.
CONCLUSION: Three months of induction chemotherapy may successfully downstage a significant proportion of patients with early-stage rectal cancer, allowing well-tolerated organ-preserving surgery.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:41 |
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| Enthalten in: |
Journal of clinical oncology : official journal of the American Society of Clinical Oncology - 41(2023), 2 vom: 10. Jan., Seite 233-242 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Kennecke, Hagen F [VerfasserIn] |
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| Links: |
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| Themen: |
04ZR38536J |
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| Anmerkungen: |
Date Completed 09.01.2023 Date Revised 08.02.2023 published: Print-Electronic ClinicalTrials.gov: NCT03259035 Citation Status MEDLINE |
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| doi: |
10.1200/JCO.22.00184 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM344998649 |
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| 100 | 1 | |a Kennecke, Hagen F |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Neoadjuvant Chemotherapy, Excision, and Observation for Early Rectal Cancer |b The Phase II NEO Trial (CCTG CO.28) Primary End Point Results |
| 264 | 1 | |c 2023 | |
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| 500 | |a Date Completed 09.01.2023 | ||
| 500 | |a Date Revised 08.02.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT03259035 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a PURPOSE: Organ-sparing therapy for early-stage I/IIA rectal cancer is intended to avoid functional disturbances or a permanent ostomy associated with total mesorectal excision (TME). The objective of this phase II trial was to determine the outcomes and organ-sparing rate of patients with early-stage rectal cancer treated with neoadjuvant chemotherapy followed by transanal excision surgery (TES) | ||
| 520 | |a METHODS: This phase II trial included patients with clinical T1-T3abN0 low- or mid-rectal adenocarcinoma eligible for endoscopic resection who were treated with 3 months of chemotherapy (modified folinic acid-fluorouracil-oxaliplatin 6 or capecitabine-oxaliplatin). Those with evidence of response proceeded to transanal endoscopic surgery 2-6 weeks later. The primary end point was protocol-specified organ preservation rate, defined as the proportion of patients with tumor downstaging to ypT0/T1N0/X and who avoided radical surgery | ||
| 520 | |a RESULTS: Of 58 patients enrolled, all commenced chemotherapy and 56 proceeded to surgery. A total of 33/58 patients had tumor downstaging to ypT0/1N0/X on the surgery specimen, resulting in an intention-to-treat protocol-specified organ preservation rate of 57% (90% CI, 45 to 68). Of 23 remaining patients recommended for TME surgery on the basis of protocol requirements, 13 declined and elected to proceed directly to observation resulting in 79% (90% CI, 69 to 88) achieving organ preservation. The remaining 10/23 patients proceeded to recommended TME of whom seven had no histopathologic residual disease. The 1-year and 2-year locoregional relapse-free survival was, respectively, 98% (95% CI, 86 to 100) and 90% (95% CI, 58 to 98), and there were no distant recurrences or deaths. Minimal change in quality of life and rectal function scores was observed | ||
| 520 | |a CONCLUSION: Three months of induction chemotherapy may successfully downstage a significant proportion of patients with early-stage rectal cancer, allowing well-tolerated organ-preserving surgery | ||
| 650 | 4 | |a Clinical Trial, Phase II | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 7 | |a Oxaliplatin |2 NLM | |
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| 700 | 1 | |a Loree, Jonathan M |e verfasserin |4 aut | |
| 700 | 1 | |a Moloo, Hussein |e verfasserin |4 aut | |
| 700 | 1 | |a Auer, Rebecca |e verfasserin |4 aut | |
| 700 | 1 | |a Jonker, Derek J |e verfasserin |4 aut | |
| 700 | 1 | |a Raval, Manoj |e verfasserin |4 aut | |
| 700 | 1 | |a Musselman, Reilly |e verfasserin |4 aut | |
| 700 | 1 | |a Ma, Grace |e verfasserin |4 aut | |
| 700 | 1 | |a Caycedo-Marulanda, Antonio |e verfasserin |4 aut | |
| 700 | 1 | |a Simianu, Vlad V |e verfasserin |4 aut | |
| 700 | 1 | |a Patel, Sunil |e verfasserin |4 aut | |
| 700 | 1 | |a Pitre, Lacey D |e verfasserin |4 aut | |
| 700 | 1 | |a Helewa, Ramzi |e verfasserin |4 aut | |
| 700 | 1 | |a Gordon, Vallerie L |e verfasserin |4 aut | |
| 700 | 1 | |a Neumann, Katerina |e verfasserin |4 aut | |
| 700 | 1 | |a Nimeiri, Halla |e verfasserin |4 aut | |
| 700 | 1 | |a Sherry, Max |e verfasserin |4 aut | |
| 700 | 1 | |a Tu, Dongsheng |e verfasserin |4 aut | |
| 700 | 1 | |a Brown, Carl J |e verfasserin |4 aut | |
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