1.Phase III double-blind randomized placebo controlled trial of atezolizumab in combination with carboplatin and paclitaxel in women with advanced/recurrent endometrial carcinoma: the Asian cohort of the AtTEnd/ENGOT-EN7 trial
Kenichi HARANO ; Roldano FOSSATI ; Beatriz PARDO ; Francesca GALLI ; Emma HUDSON ; Yoland ANTILL ; Chulmin LEE ; Manuela RABAGLIO ; Florian HEITZ ; Vassiliki KOLOVETSIOU-KREINER ; Chyong-Huey LAI ; Elena BIAGIOLI ; Luis MANSO ; Shin NISHIO ; Karen ALLAN ; Yeh Chen LEE ; Sara UGGERI ; Andres REDONDO ; Satoshi NAKAGAWA ; Eunice AU ; Janine LOMBARD ; Angiolo GADDUCCI ; Kazuhiro TAKEHARA ; Edi Editta BALDINI ; Innocenza PALAIA ; Claudia CASANOVA ; Antonio ARDIZZOIA ; Alessandra BOLOGNA ; Maria-Pilar BARRETINA-GINESTA ; Nicoletta COLOMBO
Journal of Gynecologic Oncology 2025;36(4):e117-
Objective:
This post-hoc analysis of the AtTEnd trial explored differences in the prognostic characteristics and in the efficacy of atezolizumab between Asians and non-Asians.
Methods:
The role of Asian race was evaluated on progression-free survival (PFS) using Cox-models and on time to appearance of new lesions using Fine and Gray models.
Results:
From October 2018 to February 2022, 549 patients were randomized, of whom, 20.4% were Asian. Asians showed a better prognostic profile in terms of age, body mass index, Eastern Cooperative Oncology Group performance status, disease status and previous treatments. The prognostic impact of Asian race on PFS was confirmed in the placebo arm (adjusted hazard ratio [HR]=0.41; 95% confidence interval [CI]=0.24–0.70). In proficient mismatch repair (pMMR) tumors, the HRs for PFS comparing atezolizumab versus placebo were 0.82 (95% CI=0.63–1.05) in non-Asians, and 1.42 (95% CI=0.80–2.50) in Asians. In the pMMR population randomized to atezolizumab, the subdistribution HRs comparing Asians to non-Asians were 0.68 (95% CI=0.43–1.09) for progression with new lesions and 1.21 (95% CI=0.73–2.03) for progression without new lesions. Asians showed a higher occurrence of severe adverse events in atezolizumab compared to placebo arm (Asians: 82.1% vs. 64.3%, p=0.036; non-Asian: 63.3% vs. 63.6%, p=0.949).
Conclusion
Race seems to affect the safety of the addition of atezolizumab and, in pMMR tumors, also its efficacy. In the atezolizumab arm, Asian patients seem to have a lower cumulative incidence of new lesions when primary tumor regrowth was considered a competing risk, and a higher cumulative incidence of primary tumor regrowth when new lesions appearance was the competing risk.
2.Pembrolizumab plus chemotherapy with or without bevacizumab in East Asian participants with persistent, recurrent, or metastatic cervical cancer: results from KEYNOTE-826final analysis
Yong-Man KIM ; Shin NISHIO ; Se Ik KIM ; Kosei HASEGAWA ; Coraline DUBOT ; M. Valeria CÁCERES ; Krishnansu S. TEWARI ; Domenica LORUSSO ; Jeong-Won LEE ; Wen-Shiung LIOU ; Kan LI ; Cumhur TEKIN ; Nicoletta COLOMBO ; Bradley J. MONK
Journal of Gynecologic Oncology 2025;36(4):e110-
Objective:
In the phase 3 KEYNOTE-826 study (NCT03635567), pembrolizumab plus chemotherapy with or without bevacizumab significantly improved progression-free survival (PFS) and overall survival (OS) in participants with persistent, recurrent, or metastatic cervical cancer. We report an exploratory analysis of outcomes for participants enrolled in East Asia based on the final analysis of KEYNOTE-826.
Methods:
Participants were randomized 1:1 to receive pembrolizumab 200 mg or placebo every 3 weeks for up to 35 cycles. All participants received chemotherapy with paclitaxel and cisplatin or carboplatin for up to 6 cycles, and optionally received bevacizumab at the investigator’s discretion. PFS and OS were dual primary endpoints.
Results:
Ninety-seven participants from East Asia were enrolled in the intention-to-treat population. At data cutoff (October 3, 2022), in the intention-to-treat population, median PFS in the pembrolizumab plus chemotherapy and placebo plus chemotherapy groups was 18.0 and 10.4 months, respectively (hazard ratio [HR]=0.42; 95% confidence interval [CI]=0.23−0.77); median OS was not reached and 20.4 months, respectively (HR=0.53;95% CI=0.28−0.99). In the programmed cell death ligand 1 combined positive score (CPS) ≥1 population, median PFS was 29.3 and 10.9 months, respectively (HR=0.36; 95% CI=0.19−0.68); median OS was not reached and 17.4 months, respectively (HR=0.43; 95% CI=0.22−0.86). The most common adverse events with pembrolizumab plus chemotherapy versus placebo plus chemotherapy were alopecia (75% vs. 68%) and anemia (67% vs. 65%).
Conclusion
These data support the use of pembrolizumab plus chemotherapy with or without bevacizumab for the treatment of persistent, recurrent, or metastatic cervical cancer in East Asian patients.
3.Evaluation of perioperative management of advanced ovarian (tubal/peritoneal) cancer patients: a survey from MITO-MaNGO Groups
Stefano GREGGI ; Francesca FALCONE ; Giovanni D. ALETTI ; Marco CASCELLA ; Francesca BIFULCO ; Nicoletta COLOMBO ; Sandro PIGNATA
Journal of Gynecologic Oncology 2022;33(5):e60-
Objective:
The European Society of Gynaecological Oncology (ESGO)-quality indicators (QIs) for advanced ovarian cancer (AOC) have been assessed only by few Italian centers, and data are not available on the proportion of centers reaching the score considered for a satisfactory surgical management. There is great consensus that the Enhanced Recovery After Surgery (ERAS) approach is beneficial, but there is paucity of data concerning its application in AOC. This survey was aimed at gathering detailed information on perioperative management of AOC patients within MITO-MaNGO Groups.
Methods:
A 66-item questionnaire, covering ESGO-QIs for AOC and ERAS items, was sent to MITO/MaNGO centers reporting to operate >20 AOC/year.
Results:
Thirty/34 questionnaires were analyzed. The median ESGO-QIs score was 31.5, with 50% of centers resulting with a score ≥32 which provides satisfactory surgical management. The rates of concordance with ERAS guidelines were 46.6%, 74.1%, and 60.7%, respectively, for pre-operative, intra-operative, and post-operative items. The proportion of overall agreement was 61.3%, and with strong recommendations was 63.1%. Pre-operative diet, fasting/bowel preparation, correction of anaemia, post-operative feeding and early mobilization were the most controversial. A significant positive correlation was found between ESGO-QIs score and adherence to ERAS recommendations.
Conclusion
This survey reveals a satisfactory surgical management in only half of the centers, and an at least sufficient adherence to ERAS recommendations. Higher the ESGO-QIs score stronger the adherence to ERAS recommendations, underlining the correlations between case volume, appropriate peri-operative management and quality of surgery. The present study is a first step to build a structured platform for harmonization within MITO-MaNGO networks.

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