Publish-induction chemoradiotherapy (CRT) enhanced resectability, when as opposed with chemotherapy by itself, in patients with unresectable, regionally advanced pancreatic cancer, according to research offered at the 2022 ASCO Once-a-year Assembly.
These initial success from the CONKO-007 trial uncovered that R0 and circumferential resection margin (CRM)-unfavorable resection charges were being increased with CRT. Having said that, overall survival (OS) results had been equivalent with CRT and chemotherapy alone.
The section 3 CONKO-007 demo (ClinicalTrials.gov Identifier: NCT01827553) was designed to compare CRT with chemotherapy by itself for individuals who experienced now acquired 3 months of induction chemotherapy (3 cycles of gemcitabine [1000 mg/m² on days 1, 8, and 15, every 4 weeks] or 6 cycles of FOLFIRINOX [every 2 weeks]).
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The individuals with no progression after induction were randomly assigned to either carry on chemotherapy for one more 3 months or receive CRT (cumulative dose of 50.4 Gy, solitary dose of 1.8 Gy furthermore gemcitabine at 300 mg/m² weekly, followed by 1 cycle of gemcitabine at 1000 mg/m² on times 1, 8, and 15).
A full of 525 clients had been enrolled in between April 2013 and February 2021 at 47 websites. Most clients (n=402) obtained induction with FOLFIRINOX, and 93 been given gemcitabine. After induction was accomplished, 190 people were being excluded because of to development or toxicity. For that reason, 169 patients went on to get CRT, and 167 went on to get chemotherapy by itself.
Hematologic toxicities, especially leukopenia and thrombocytopenia, had been observed more frequently in the CRT arm. The researchers noted that these adverse gatherings had been perfectly managed, and remedy-associated deaths ended up similarly dispersed in between the 2 treatment arms. Non-hematologic toxicities ended up also similar amongst the remedy arms.
In wanting at individuals who underwent resection, R0 resections ended up drastically bigger in clients who gained CRT than in these who acquired chemotherapy on your own (69% vs 50%, respectively P =.0418). CRM-damaging resection was far more frequently observed in the CRT arm than in the chemotherapy-on your own arm (47% vs 25%, respectively P =.0147).
The pathologic entire remission price was better in the CRT arm than in the chemotherapy arm (18% vs 2% P =.0043). The results trended likewise when facts from all randomly assigned sufferers were being bundled.
The result of CRT on resectability did not translate into important improvements in development-free of charge survival (PFS) or overall survival (OS). In all randomized sufferers, the median PFS was 8 months in the chemotherapy arm and 9 months in the CRT arm (hazard ratio [HR], .976 P =.835). The median OS was 15 months in equally arms (HR, .975 P =.713).
There was a important enhancement in OS for people who underwent surgical treatment, as opposed with these who did not. The median OS was 19 months and 14 months, respectively (HR, .573 P <.001).
Similarly, there were significant improvements in OS for patients who had R0 and CRM-negative resections, compared with those who did not. The median OS was 26 months in patients with R0 resection and 17 months in those with R1 resection (HR, 0.2155 P =.006). The median OS was 36 months in patients with CRM-negative resection and 18 months in those with CRM-positive resection (HR, 0.2293 P =.002).
According to the researchers, these results suggest that R0 and CRM-negative resections are important for long-term survival in this patient population, and CRT plus surgery after induction chemotherapy is feasible.
Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Fietkau R, Ghadimi M, Grützmann R, et al. Randomized phase III trial of induction chemotherapy followed by chemoradiotherapy or chemotherapy alone for nonresectable locally advanced pancreatic cancer: First results of the CONKO-007 trial. Presented at ASCO 2022. June 3-7, 2022. Abstract 4008.