Matches in SemOpenAlex for { <https://semopenalex.org/work/W3088975884> ?p ?o ?g. }
Showing items 1 to 72 of
72
with 100 items per page.
- W3088975884 endingPage "S903" @default.
- W3088975884 startingPage "S903" @default.
- W3088975884 abstract "Perioperative chemotherapy improves cure rate in locally advanced gastroesophageal adenocarcinoma (GEA), and immune checkpoint inhibitors are active at the metastatic stage. This trial tests the hypothesis that the addition of Avelumab to perioperative chemotherapy will increase the pathologic complete response rate (pCR) in comparison with historical controls. Phase II study of Avelumab + chemotherapy (mDCF) given every 2 weeks for 4 cycles before and after surgery. Main inclusion criteria: GEA, cT3 and/or cN+, WHO PS 0-1. Main exclusion criteria: other histology, metastatic stage, use of immunosuppressants, serious autoimmune disease, daily intake >10 mg prednisone. Staging studies: CT, PET-CT, endoscopic ultrasound, diagnostic laparoscopy. Surgical resection: D2 lymphadenectomy, en-bloc esophagectomy for type I/II GEJ tumors. Statistical hypothesis: pCR is defined as tumor regression (modified Ryan scheme) grades 0-1; this experimental regimen will result in a 20% rate of pCR, compared with 7% with chemotherapy alone. Simon 2-stage design: if less than 2 pCR are seen in the first 16 patients, the study will be closed. The null hypothesis cannot be rejected if at least 6 pCR are seen in the first 50 patients. All adverse effects are prospectively recorded per CTCAE guidelines in patients who have received at least one treatment cycle. Feb 2018-Feb 2020: 28 patients enrolled (25 M/3 F, age 45-78). Location: gastroesophageal junction (23), stomach (5). Staging: cT3 (25), cT4 (1), cN+ (20). Grade 3 toxicity: stomatitis (2/28); nausea (2/28); vomiting (1/28); diarrhea (1/28); hypothyroidism (1/28); arthralgia (3/28); neutropenia (1/28). Grade 4 toxicity: pneumonia (1/28); neutropenia (2/28). Postoperative 30-day mortality: 0%. One patient was excluded from efficacy analyses for M1 staging; 27 patients underwent surgery, 26 with R0 (96%). Six cases (22%) show pCR: 3 grade 0 (11%) and 3 grade 1 (11%) tumor regressions. The combination of mDCF chemotherapy with Avelumab demonstrates a promising safety and activity profile. Ongoing laboratory investigations are underway to correlate our findings with tumor molecular features before exposure to treatment." @default.
- W3088975884 created "2020-10-01" @default.
- W3088975884 creator A5013744204 @default.
- W3088975884 creator A5037501509 @default.
- W3088975884 creator A5044048665 @default.
- W3088975884 creator A5044351924 @default.
- W3088975884 creator A5045534526 @default.
- W3088975884 creator A5053281271 @default.
- W3088975884 creator A5062446034 @default.
- W3088975884 creator A5063193415 @default.
- W3088975884 creator A5079391406 @default.
- W3088975884 creator A5087983305 @default.
- W3088975884 creator A5089876567 @default.
- W3088975884 date "2020-09-01" @default.
- W3088975884 modified "2023-10-18" @default.
- W3088975884 title "1429P Phase II trial of perioperative mdcf + avelumab in locally advanced gastroesophageal adenocarcinoma: Safety/efficacy" @default.
- W3088975884 doi "https://doi.org/10.1016/j.annonc.2020.08.1935" @default.
- W3088975884 hasPublicationYear "2020" @default.
- W3088975884 type Work @default.
- W3088975884 sameAs 3088975884 @default.
- W3088975884 citedByCount "0" @default.
- W3088975884 crossrefType "journal-article" @default.
- W3088975884 hasAuthorship W3088975884A5013744204 @default.
- W3088975884 hasAuthorship W3088975884A5037501509 @default.
- W3088975884 hasAuthorship W3088975884A5044048665 @default.
- W3088975884 hasAuthorship W3088975884A5044351924 @default.
- W3088975884 hasAuthorship W3088975884A5045534526 @default.
- W3088975884 hasAuthorship W3088975884A5053281271 @default.
- W3088975884 hasAuthorship W3088975884A5062446034 @default.
- W3088975884 hasAuthorship W3088975884A5063193415 @default.
- W3088975884 hasAuthorship W3088975884A5079391406 @default.
- W3088975884 hasAuthorship W3088975884A5087983305 @default.
- W3088975884 hasAuthorship W3088975884A5089876567 @default.
- W3088975884 hasBestOaLocation W30889758841 @default.
- W3088975884 hasConcept C126322002 @default.
- W3088975884 hasConcept C141071460 @default.
- W3088975884 hasConcept C2776694085 @default.
- W3088975884 hasConcept C2777063308 @default.
- W3088975884 hasConcept C2778336483 @default.
- W3088975884 hasConcept C2781413609 @default.
- W3088975884 hasConcept C31174226 @default.
- W3088975884 hasConcept C71924100 @default.
- W3088975884 hasConcept C90924648 @default.
- W3088975884 hasConceptScore W3088975884C126322002 @default.
- W3088975884 hasConceptScore W3088975884C141071460 @default.
- W3088975884 hasConceptScore W3088975884C2776694085 @default.
- W3088975884 hasConceptScore W3088975884C2777063308 @default.
- W3088975884 hasConceptScore W3088975884C2778336483 @default.
- W3088975884 hasConceptScore W3088975884C2781413609 @default.
- W3088975884 hasConceptScore W3088975884C31174226 @default.
- W3088975884 hasConceptScore W3088975884C71924100 @default.
- W3088975884 hasConceptScore W3088975884C90924648 @default.
- W3088975884 hasLocation W30889758841 @default.
- W3088975884 hasOpenAccess W3088975884 @default.
- W3088975884 hasPrimaryLocation W30889758841 @default.
- W3088975884 hasRelatedWork W136411592 @default.
- W3088975884 hasRelatedWork W1966032114 @default.
- W3088975884 hasRelatedWork W1975832547 @default.
- W3088975884 hasRelatedWork W1996986167 @default.
- W3088975884 hasRelatedWork W2020898191 @default.
- W3088975884 hasRelatedWork W2303669053 @default.
- W3088975884 hasRelatedWork W2383272827 @default.
- W3088975884 hasRelatedWork W2509837252 @default.
- W3088975884 hasRelatedWork W2954645619 @default.
- W3088975884 hasRelatedWork W3119397188 @default.
- W3088975884 hasVolume "31" @default.
- W3088975884 isParatext "false" @default.
- W3088975884 isRetracted "false" @default.
- W3088975884 magId "3088975884" @default.
- W3088975884 workType "article" @default.