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.Efficacy of repetitive transcranial magnetic stimulation (rTMS) in inducing weight loss among obese Filipino patients
Margaret Encarnacion ; Oliver Allan Dampil ; Ludwig Damian ; Maria Leila Doquenia ; Divina Cristy Redondo-Samin ; Mary Karen Woolbright
Journal of the ASEAN Federation of Endocrine Societies 2020;35(2):181-189
Objective. To determine the efficacy of rTMS in decreasing body mass index (BMI) versus sham stimulation among obese Filipino patients.
Methodology. This was a single-center, randomized, sham-controlled, single-blind, parallel group trial. Participants were 15-65 years old with BMI ≥30 kg/m2 and weight stable for 6 weeks. Participants were randomized to receive real rTMS or sham stimulation. Each underwent 4 sessions of stimulation over 2 weeks. Anthropometrics, total caloric intake (TCI), and VAS score for appetite were taken at baseline, 2, 4, 6, and 12 weeks.
Results. A total of 31 patients were randomized with 15 to the treatment and 14 to sham stimulation completing treatment, with 2 lost to follow-up. A significant decrease in BMI was noted after 4 weeks from the start of rTMS in the treatment group, (0.6±0.6, p-value=0.001), with weight change of -1.3±1.3 kg (p-value=0.009), but was no longer observed at 6 weeks onwards. No severe adverse effects were noted.
Conclusion. rTMS to the DLPFC effectively decreased BMI (0.6±0.6) and weight (-1.3±1.3 kg) from baseline to 4 weeks. At 6-12 weeks after rTMS however, there was no longer a significant difference, indicating that 4 sessions of rTMS may not be enough to produce a prolonged effect on weight loss.
weight loss
;
obesity
;
Transcranial Magnetic Stimulation
3.Endometrial carcinoma in vitro chemosensitivity testing of single and combination chemotherapy regimens using the novel microculture kinetic apoptosis assay: implications for endometrial cancer treatment.
Karen S BALLARD ; Howard D HOMESLEY ; Charles HODSON ; Cary A PRESANT ; James RUTLEDGE ; Allan HALLQUIST ; Mathieu PERREE
Journal of Gynecologic Oncology 2010;21(1):45-49
OBJECTIVE: The in vitro microculture kinetic (MiCK) apoptosis assay has been used to predict single or combination chemotherapy response in leukemia patients. This feasibility study addressed MiCK in endometrial cancer specimens. METHODS: Endometrial cancer specimens from total abdominal hysterectomies were processed at a central laboratory. Single cell suspensions of viable endometrial cancer cells were plated in individual wells. Single and combination regimens were tested: combinations of doxorubicin, cisplatin, and paclitaxel and carboplatin and paclitaxel (Gynecologic Oncology Group [GOG] 209 endometrial cancer phase III trial arms) as well as single agent testing with paclitaxel, carboplatin, doxorubicin, cisplatin, ifosfamide, and vincristine (active agents in GOG trials). Apoptosis was measured continuously over 48 hours. RESULTS: Fifteen of nineteen patients had successful assays. The highest mean chemo sensitivity was noted in the combination of cisplatin, doxorubicin, and paclitaxel with lower mean chemosensitivity for carboplatin and paclitaxel. Combination chemotherapy had higher chemosensitivity than single drug chemotherapy. However, in 25% of patients a single drug had higher chemosensitivity than combination chemotherapy. As single agents, ifosfamide, cisplatin, and paclitaxel had the highest kinetic unit values. CONCLUSION: Using a panel of agents simulating clinical dose regimens, the MiCK assay was feasible in evaluating in vitro chemosensitivity of endometrial cancer. MiCK assay results correlated with GOG clinical trial results. However, 25% of patients might be best treated with single agent chemotherapy selected by MiCK. Ifosfamide, cisplatin, and paclitaxel appear to have high activity as single agents. MiCK may be useful in future new drug testing and individualizing endometrial cancer patient's chemotherapy management.
Apoptosis
;
Carboplatin
;
Cisplatin
;
Doxorubicin
;
Drug Therapy, Combination
;
Endometrial Neoplasms
;
Feasibility Studies
;
Female
;
Humans
;
Hysterectomy
;
Ifosfamide
;
Leukemia
;
Paclitaxel
;
Suspensions
;
Vincristine


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