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BERLIN — , according to findings presented at the 2025 annual meeting of the European Society for Medical Oncology (ESMO).
Experts said the survival benefit further supports perioperative durvalumab plus FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) as the new standard of care for patients with localized gastric or gastroesophageal adenocarcinoma. Earlier results from the phase 3 MATTERHORN trial, reported at the American Society of Clinical Oncology meeting (ASCO) in June, showed that the addition of durvalumab improved event-free survival compared with FLOT alone.
The findings presented at ESMO show that at 36 months, overall survival was 68.6% among patients who received durvalumab + FLOT vs 61.9% among those given FLOT plus a placebo. After a median of 43 months, the survival advantage in the durvalumab group was statistically significant (hazard ratio [HR], 0.78; 95% CI, 0.63-0.96; P = .021) and “more importantly, clinically meaningful,” said lead investigator Josep Tabernero, MD, PhD, of Vall d’Hebron University Hospital in Barcelona.
The results “strongly support the use of perioperative durvalumab plus chemotherapy with FLOT as a new global standard of care for patients with localized gastric and gastroesophageal adenocarcinoma,” Tabernero said.
Speaking as discussant for the session, Sylvie Lorenzen, MD, PhD, Technische Universität München in Munich, Germany, was enthusiastic that the previously reported trends in MATTERHORN held strong.
“The shape of the curves presented at ASCO was already very positive,” she said. “And now, with a longer follow-up, more events, and a higher overall survival maturity, they reach statistical significance. It looks like the magnitude of the effect increases with longer follow-up, and this is important for our patients.”
The trial randomly assigned 948 patients with resectable gastric or gastroesophageal adenocarcinoma to receive either durvalumab (1500 mg) or placebo every 4 weeks, plus FLOT for 2 cycles before surgery and then again after, followed by durvalumab or placebo every 4 weeks for 10 cycles.
Patients were stratified according to lymph node status, as well as PD-L1 expression (≥ 1% or < 1%, according to the Tumor Area Positivity score.)
The improvement in overall survival with durvalumab was seen regardless of PD-L1 expression, Tabernero said, with the same hazard ratios (0.79) in both the positive and negative subgroups.
However, there was no clear overall survival benefit in certain other subgroups, including women (n = 266; HR, 0.91), those with node-negative disease (n = 277; HR, 1.01), and those with diffuse histology (n = 249; HR, 0.98).
Lorenzen said that clinicians should “pay attention” to those patient subgroups, as they seem to benefit less from the addition of durvalumab. However, she cautioned that the findings were based on small patient numbers and the confidence intervals were wide.
Tabernero also reported additional data on event-free survival (EFS). Overall, the durvalumab/FLOT combination improved EFS among patients with any degree of pathological response and irrespective of lymph node status at surgery.
Regarding nodal staging, which was done in 800 patients, the percentage who achieved negative nodal status was higher in the durvalumab group (58.2%) vs the placebo group (44.8%). However, the improvement in EFS with durvalumab was comparable for node-negative (HR, 0.74) and node-positive (HR, 0.77) patients.
Lorenzen said that overall, the results provide a solid answer to the question, “Is it time to change practice?”
“I think MATTERHORN gives us the largest dataset and answers this question satisfactorily,” she said. Given that overall survival improved regardless of PD-L1 expression, she added, the combination of durvalumab and FLOT should be offered to “all our patient subgroups.”
The study was funded by AstraZeneca. Tabernero made numerous disclosures, including relationships with AstraZeneca, Boehringer Ingelheim, Chugai, and Daichii Sankyo. Lorenzen disclosed financial interests in or serving as an invited speaker for Servier, Lilly, MSD, and BMS.
A version of this article appeared on Medscape.com .
BERLIN — , according to findings presented at the 2025 annual meeting of the European Society for Medical Oncology (ESMO).
Experts said the survival benefit further supports perioperative durvalumab plus FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) as the new standard of care for patients with localized gastric or gastroesophageal adenocarcinoma. Earlier results from the phase 3 MATTERHORN trial, reported at the American Society of Clinical Oncology meeting (ASCO) in June, showed that the addition of durvalumab improved event-free survival compared with FLOT alone.
The findings presented at ESMO show that at 36 months, overall survival was 68.6% among patients who received durvalumab + FLOT vs 61.9% among those given FLOT plus a placebo. After a median of 43 months, the survival advantage in the durvalumab group was statistically significant (hazard ratio [HR], 0.78; 95% CI, 0.63-0.96; P = .021) and “more importantly, clinically meaningful,” said lead investigator Josep Tabernero, MD, PhD, of Vall d’Hebron University Hospital in Barcelona.
The results “strongly support the use of perioperative durvalumab plus chemotherapy with FLOT as a new global standard of care for patients with localized gastric and gastroesophageal adenocarcinoma,” Tabernero said.
Speaking as discussant for the session, Sylvie Lorenzen, MD, PhD, Technische Universität München in Munich, Germany, was enthusiastic that the previously reported trends in MATTERHORN held strong.
“The shape of the curves presented at ASCO was already very positive,” she said. “And now, with a longer follow-up, more events, and a higher overall survival maturity, they reach statistical significance. It looks like the magnitude of the effect increases with longer follow-up, and this is important for our patients.”
The trial randomly assigned 948 patients with resectable gastric or gastroesophageal adenocarcinoma to receive either durvalumab (1500 mg) or placebo every 4 weeks, plus FLOT for 2 cycles before surgery and then again after, followed by durvalumab or placebo every 4 weeks for 10 cycles.
Patients were stratified according to lymph node status, as well as PD-L1 expression (≥ 1% or < 1%, according to the Tumor Area Positivity score.)
The improvement in overall survival with durvalumab was seen regardless of PD-L1 expression, Tabernero said, with the same hazard ratios (0.79) in both the positive and negative subgroups.
However, there was no clear overall survival benefit in certain other subgroups, including women (n = 266; HR, 0.91), those with node-negative disease (n = 277; HR, 1.01), and those with diffuse histology (n = 249; HR, 0.98).
Lorenzen said that clinicians should “pay attention” to those patient subgroups, as they seem to benefit less from the addition of durvalumab. However, she cautioned that the findings were based on small patient numbers and the confidence intervals were wide.
Tabernero also reported additional data on event-free survival (EFS). Overall, the durvalumab/FLOT combination improved EFS among patients with any degree of pathological response and irrespective of lymph node status at surgery.
Regarding nodal staging, which was done in 800 patients, the percentage who achieved negative nodal status was higher in the durvalumab group (58.2%) vs the placebo group (44.8%). However, the improvement in EFS with durvalumab was comparable for node-negative (HR, 0.74) and node-positive (HR, 0.77) patients.
Lorenzen said that overall, the results provide a solid answer to the question, “Is it time to change practice?”
“I think MATTERHORN gives us the largest dataset and answers this question satisfactorily,” she said. Given that overall survival improved regardless of PD-L1 expression, she added, the combination of durvalumab and FLOT should be offered to “all our patient subgroups.”
The study was funded by AstraZeneca. Tabernero made numerous disclosures, including relationships with AstraZeneca, Boehringer Ingelheim, Chugai, and Daichii Sankyo. Lorenzen disclosed financial interests in or serving as an invited speaker for Servier, Lilly, MSD, and BMS.
A version of this article appeared on Medscape.com .
BERLIN — , according to findings presented at the 2025 annual meeting of the European Society for Medical Oncology (ESMO).
Experts said the survival benefit further supports perioperative durvalumab plus FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) as the new standard of care for patients with localized gastric or gastroesophageal adenocarcinoma. Earlier results from the phase 3 MATTERHORN trial, reported at the American Society of Clinical Oncology meeting (ASCO) in June, showed that the addition of durvalumab improved event-free survival compared with FLOT alone.
The findings presented at ESMO show that at 36 months, overall survival was 68.6% among patients who received durvalumab + FLOT vs 61.9% among those given FLOT plus a placebo. After a median of 43 months, the survival advantage in the durvalumab group was statistically significant (hazard ratio [HR], 0.78; 95% CI, 0.63-0.96; P = .021) and “more importantly, clinically meaningful,” said lead investigator Josep Tabernero, MD, PhD, of Vall d’Hebron University Hospital in Barcelona.
The results “strongly support the use of perioperative durvalumab plus chemotherapy with FLOT as a new global standard of care for patients with localized gastric and gastroesophageal adenocarcinoma,” Tabernero said.
Speaking as discussant for the session, Sylvie Lorenzen, MD, PhD, Technische Universität München in Munich, Germany, was enthusiastic that the previously reported trends in MATTERHORN held strong.
“The shape of the curves presented at ASCO was already very positive,” she said. “And now, with a longer follow-up, more events, and a higher overall survival maturity, they reach statistical significance. It looks like the magnitude of the effect increases with longer follow-up, and this is important for our patients.”
The trial randomly assigned 948 patients with resectable gastric or gastroesophageal adenocarcinoma to receive either durvalumab (1500 mg) or placebo every 4 weeks, plus FLOT for 2 cycles before surgery and then again after, followed by durvalumab or placebo every 4 weeks for 10 cycles.
Patients were stratified according to lymph node status, as well as PD-L1 expression (≥ 1% or < 1%, according to the Tumor Area Positivity score.)
The improvement in overall survival with durvalumab was seen regardless of PD-L1 expression, Tabernero said, with the same hazard ratios (0.79) in both the positive and negative subgroups.
However, there was no clear overall survival benefit in certain other subgroups, including women (n = 266; HR, 0.91), those with node-negative disease (n = 277; HR, 1.01), and those with diffuse histology (n = 249; HR, 0.98).
Lorenzen said that clinicians should “pay attention” to those patient subgroups, as they seem to benefit less from the addition of durvalumab. However, she cautioned that the findings were based on small patient numbers and the confidence intervals were wide.
Tabernero also reported additional data on event-free survival (EFS). Overall, the durvalumab/FLOT combination improved EFS among patients with any degree of pathological response and irrespective of lymph node status at surgery.
Regarding nodal staging, which was done in 800 patients, the percentage who achieved negative nodal status was higher in the durvalumab group (58.2%) vs the placebo group (44.8%). However, the improvement in EFS with durvalumab was comparable for node-negative (HR, 0.74) and node-positive (HR, 0.77) patients.
Lorenzen said that overall, the results provide a solid answer to the question, “Is it time to change practice?”
“I think MATTERHORN gives us the largest dataset and answers this question satisfactorily,” she said. Given that overall survival improved regardless of PD-L1 expression, she added, the combination of durvalumab and FLOT should be offered to “all our patient subgroups.”
The study was funded by AstraZeneca. Tabernero made numerous disclosures, including relationships with AstraZeneca, Boehringer Ingelheim, Chugai, and Daichii Sankyo. Lorenzen disclosed financial interests in or serving as an invited speaker for Servier, Lilly, MSD, and BMS.
A version of this article appeared on Medscape.com .