Hitoshi Masuda
Current Organizations / Institutes
The organizations/institutes from the scholar's latest article
Research Subjects
Hitoshi Masuda has a total of 124 co-authors. Here are the top co-authors by number of shared publications:
- Shugo Yajima
National Cancer Center-Hospital East: Kokuritsu Gan Center Higashi Byoin
26 shared publications - Yasukazu Nakanishi
Department of Urology National Cancer Center Hospital East Kashiwa Chiba Japan
18 shared publications - Madoka Kataoka
Department of Urology, National Cancer Center Hospital East, Chiba, Japan
9 shared publications - Kenji Tanabe
Department of Urology Institute of Science Tokyo Tokyo Japan
7 shared publications - Soichiro Yoshida
Department of Urology Institute of Science Tokyo Tokyo Japan
7 shared publications - Yasuhisa Fujii
Department of Urology Institute of Science Tokyo Tokyo Japan
6 shared publications
Latest Publications
- 3 November 2026
- Published by Wiley in International Journal of Urology
- Vol. 33 (11)
Sensitivity of mHSPC Overall Survival Network Estimates to the Historical Docetaxel Bridge
- 3 November 2026
- Published by Wiley in International Journal of Urology
- Vol. 33 (11)
Sensitivity of mHSPC Overall Survival Network Estimates to the Historical Docetaxel Bridge
- Open Access
- 29 October 2026
- Published by Wiley in IJU Case Reports
- Vol. 9 (6)
Multidisciplinary Treatment of Abdominal Wall Recurrence After Bladder Perforation During Transurethral Resection of a Bladder Tumor
Introduction: Sarcomatoid urothelial carcinoma is a rare, highly aggressive bladder cancer subtype. We report the first case of abdominal wall implantation of sarcomatoid urothelial carcinoma after bladder perforation during transurethral resection of a bladder tumor, followed by recurrence at the open repair site requiring further resection. Case Presentation: A 73‐year‐old woman underwent emergency transurethral resection for a rapidly enlarging bladder tumor complicated by full‐thickness perforation. Histopathology revealed sarcomatoid urothelial carcinoma. During intravesical bacillus Calmette–Guérin therapy, she developed a malignant right lower abdominal wall mass attributed to tumor implantation. Enfortumab vedotin plus pembrolizumab did not prevent progression. Preoperative radiotherapy was followed by en bloc resection with partial cystectomy and anterolateral thigh flap reconstruction. Pathology demonstrated extensive treatment‐related necrosis and negative margins. She remained recurrence‐free at 11 months. Conclusion: For localized recurrence, aggressive multidisciplinary treatment incorporating radical local resection and reconstructive surgery may provide local disease control in selected patients without metastasis.
- 29 October 2026
- Published by Wiley in IJU Case Reports
- Vol. 9 (6)
Open AccessMultidisciplinary Treatment of Abdominal Wall Recurrence After Bladder Perforation During Transurethral Resection of a Bladder Tumor
Introduction: Sarcomatoid urothelial carcinoma is a rare, highly aggressive bladder cancer subtype. We report the first case of abdominal wall implantation of sarcomatoid urothelial carcinoma after bladder perforation during transurethral resection of a bladder tumor, followed by recurrence at the open repair site requiring further resection. Case Presentation: A 73‐year‐old woman underwent emergency transurethral resection for a rapidly enlarging bladder tumor complicated by full‐thickness perforation. Histopathology revealed sarcomatoid urothelial carcinoma. During intravesical bacillus Calmette–Guérin therapy, she developed a malignant right lower abdominal wall mass attributed to tumor implantation. Enfortumab vedotin plus pembrolizumab did not prevent progression. Preoperative radiotherapy was followed by en bloc resection with partial cystectomy and anterolateral thigh flap reconstruction. Pathology demonstrated extensive treatment‐related necrosis and negative margins. She remained recurrence‐free at 11 months. Conclusion: For localized recurrence, aggressive multidisciplinary treatment incorporating radical local resection and reconstructive surgery may provide local disease control in selected patients without metastasis.
- Open Access
- 14 October 2026
- Published by Wiley in IJU Case Reports
- Vol. 9 (6) , e70281
Simultaneous Robot‐Assisted Distal Gastrectomy and Radical Cystectomy With a Shared Port Configuration in Situs Inversus Totalis
Introduction: Situs inversus totalis complicates minimally invasive surgery, and simultaneous robotic surgery for tumors of different organs is particularly challenging. Case Presentation: A 72‐year‐old man with situs inversus totalis receiving androgen blockade for prostate cancer developed a 40‐mm muscle‐invasive bladder tumor undetected on magnetic resonance imaging 7 months earlier; synchronous gastric cancer was also diagnosed. After four chemotherapy cycles, robot‐assisted distal gastrectomy and radical cystectomy with an ileal conduit were performed in one session, sharing four of eight ports and lasting 10 h 27 min. The bladder showed no residual carcinoma (ypT0N0) and the gastric cancer ypT2N3aM0; he died 27 months postoperatively. Conclusion: Two major robotic resections were completed in one session, to our knowledge for the first time. Port sharing avoided a second set of incisions and a second port map, although the robot was undocked and redocked. The surgery was prolonged and followed by suspected non‐occlusive mesenteric ischemia.
- 14 October 2026
- Published by Wiley in IJU Case Reports
- Vol. 9 (6) , e70281
Open AccessSimultaneous Robot‐Assisted Distal Gastrectomy and Radical Cystectomy With a Shared Port Configuration in Situs Inversus Totalis
Introduction: Situs inversus totalis complicates minimally invasive surgery, and simultaneous robotic surgery for tumors of different organs is particularly challenging. Case Presentation: A 72‐year‐old man with situs inversus totalis receiving androgen blockade for prostate cancer developed a 40‐mm muscle‐invasive bladder tumor undetected on magnetic resonance imaging 7 months earlier; synchronous gastric cancer was also diagnosed. After four chemotherapy cycles, robot‐assisted distal gastrectomy and radical cystectomy with an ileal conduit were performed in one session, sharing four of eight ports and lasting 10 h 27 min. The bladder showed no residual carcinoma (ypT0N0) and the gastric cancer ypT2N3aM0; he died 27 months postoperatively. Conclusion: Two major robotic resections were completed in one session, to our knowledge for the first time. Port sharing avoided a second set of incisions and a second port map, although the robot was undocked and redocked. The surgery was prolonged and followed by suspected non‐occlusive mesenteric ischemia.
- 29 September 2026
- Published by Wiley in International Journal of Urology
- Vol. 33 (10) , e70657
Editorial Comment to Intraoperative Near‐Infrared Fluorescence Imaging for Qualitative Perfusion Assessment of the Redundant Renal Pelvis After Renal Pelvic Transection in Robot‐Assisted Laparoscopic Pyeloplasty
- 29 September 2026
- Published by Wiley in International Journal of Urology
- Vol. 33 (10) , e70657
Editorial Comment to Intraoperative Near‐Infrared Fluorescence Imaging for Qualitative Perfusion Assessment of the Redundant Renal Pelvis After Renal Pelvic Transection in Robot‐Assisted Laparoscopic Pyeloplasty
- 6 September 2026
- Published by Wiley in Journal of Surgical Oncology
Treatment Selection and Survival In Muscle‐Invasive Bladder Cancer: Real‐World Data on the Impact of Geriatric‐8 Screening
Aim: Standard treatment for muscle‐invasive bladder cancer (MIBC) includes radical cystectomy (RC), a highly invasive procedure. We evaluated the utility of the Geriatric‐8 (G8) screening tool in guiding treatment and whether the survival benefit of RC differs by G8 score. Methods: We retrospectively reviewed patients with non‐metastatic MIBC who underwent G8 assessment (2020–2024). Patients were grouped by G8: low (14). Treatment patterns and the effectiveness of RC were evaluated. Results: A total of 152 patients were included (high: n = 55, intermediate: n = 67, low: n = 30). RC was performed in 124 patients (81.6%). Lower G8 was linked to older age, poorer performance status, and dependent instrumental activities of daily living ( p < 0.01). Neoadjuvant chemotherapy followed by RC was more frequently planned in the high G8 group (81.8% vs. 53.7% vs. 26.7%, p < 0.0001), while immediate RC was a more common plan in the low G8 group (14.5% vs. 41.8% vs. 53.3%, p = 0.0003). RC was associated with significantly improved overall survival, and the benefit persisted after propensity score matching ( p = 0.0013). Inverse probability of treatment weighting, which retained the whole cohort, gave a consistent estimate (hazard ratio [HR] 0.17, 95% confidence interval [CI] 0.08–0.39). Subgroup estimates were less precise in the low G8 group (HR 0.57, 95% CI 0.12–2.73) than in the intermediate (HR 0.14, 95% CI 0.06–0.33) and high (HR 0.10, 95% CI 0.02–0.39) groups. In sliding window analysis, HR estimates were higher at G8 < 9, with wide CIs. Similar results were observed for cancer‐specific survival. Conclusions: RC was associated with a survival benefit in patients with intermediate and high G8 scores, whereas the evidence in the low G8 group was limited and inconclusive; careful risk–benefit evaluation remains warranted in this group.
- 6 September 2026
- Published by Wiley in Journal of Surgical Oncology
Treatment Selection and Survival In Muscle‐Invasive Bladder Cancer: Real‐World Data on the Impact of Geriatric‐8 Screening
Aim: Standard treatment for muscle‐invasive bladder cancer (MIBC) includes radical cystectomy (RC), a highly invasive procedure. We evaluated the utility of the Geriatric‐8 (G8) screening tool in guiding treatment and whether the survival benefit of RC differs by G8 score. Methods: We retrospectively reviewed patients with non‐metastatic MIBC who underwent G8 assessment (2020–2024). Patients were grouped by G8: low (14). Treatment patterns and the effectiveness of RC were evaluated. Results: A total of 152 patients were included (high: n = 55, intermediate: n = 67, low: n = 30). RC was performed in 124 patients (81.6%). Lower G8 was linked to older age, poorer performance status, and dependent instrumental activities of daily living ( p < 0.01). Neoadjuvant chemotherapy followed by RC was more frequently planned in the high G8 group (81.8% vs. 53.7% vs. 26.7%, p < 0.0001), while immediate RC was a more common plan in the low G8 group (14.5% vs. 41.8% vs. 53.3%, p = 0.0003). RC was associated with significantly improved overall survival, and the benefit persisted after propensity score matching ( p = 0.0013). Inverse probability of treatment weighting, which retained the whole cohort, gave a consistent estimate (hazard ratio [HR] 0.17, 95% confidence interval [CI] 0.08–0.39). Subgroup estimates were less precise in the low G8 group (HR 0.57, 95% CI 0.12–2.73) than in the intermediate (HR 0.14, 95% CI 0.06–0.33) and high (HR 0.10, 95% CI 0.02–0.39) groups. In sliding window analysis, HR estimates were higher at G8 < 9, with wide CIs. Similar results were observed for cancer‐specific survival. Conclusions: RC was associated with a survival benefit in patients with intermediate and high G8 scores, whereas the evidence in the low G8 group was limited and inconclusive; careful risk–benefit evaluation remains warranted in this group.
- 28 August 2026
- Published by Wiley in LUTS: Lower Urinary Tract Symptoms
- Vol. 18 (5)
Efficacy of Vibegron in Overactive Bladder: A Bayesian Cross‐Trial Synthesis of Benefit Probabilities and Decision Thresholds
Objectives: To synthesize published placebo‐controlled trials of vibegron monotherapy for overactive bladder (OAB) and quantify posterior probabilities of benefit and decision‐threshold exceedance. Methods: We extracted published placebo‐adjusted least‐squares mean differences at Week 12 from three randomized, double‐blind, placebo‐controlled Phase III trials evaluating vibegron monotherapy (Japan Phase III trial, Korea bridging study [50 mg], and EMPOWUR trial [75 mg]) for four voiding‐diary endpoints: micturitions/day, urgency episodes/day, urgency urinary incontinence (UUI) episodes/day, and voided volume (mL). For each endpoint, a Bayesian normal–normal random‐effects model estimated the pooled mean effect and between‐trial heterogeneity and calculated posterior probabilities of benefit and of exceeding thresholds predefined in this analysis. Results: Pooled mean effects (95% credible intervals) favored vibegron across all four voiding‐diary endpoints: micturitions/day (−0.76, −1.33 to −0.28), urgency episodes/day (−0.69, −1.35 to −0.22), UUI episodes/day (−0.44, −0.93 to −0.03), and voided volume (+24.09 mL, 15.78–32.51). The posterior probabilities of benefit were 99.5%, 99.3%, 98.0%, and > 99.9%, respectively. The probabilities of exceeding thresholds were as follows: for micturitions/day, ≤ −0.5: 90.3% and ≤ −1.0: 14.2%; for urgency episodes/day, ≤ −0.5: 82.8% and ≤ −1.0: 12.7%; for UUI episodes/day, ≤ −0.3: 81.8% and ≤ −0.5: 35.4%; and for voided volume, ≥ +10 mL: 99.5%, ≥ +20 mL: 88.4%, and ≥ +30 mL: 5.8%. Conclusions: Bayesian cross‐trial synthesis demonstrates a high probability that vibegron improves key OAB voiding‐diary outcomes at Week 12. By explicitly quantifying the probability of exceeding clinically interpretable decision thresholds, this approach provides a transparent assessment of both the direction and magnitude of treatment effects, facilitating clinically interpretable decision‐making.
- 28 August 2026
- Published by Wiley in LUTS: Lower Urinary Tract Symptoms
- Vol. 18 (5)
Efficacy of Vibegron in Overactive Bladder: A Bayesian Cross‐Trial Synthesis of Benefit Probabilities and Decision Thresholds
Objectives: To synthesize published placebo‐controlled trials of vibegron monotherapy for overactive bladder (OAB) and quantify posterior probabilities of benefit and decision‐threshold exceedance. Methods: We extracted published placebo‐adjusted least‐squares mean differences at Week 12 from three randomized, double‐blind, placebo‐controlled Phase III trials evaluating vibegron monotherapy (Japan Phase III trial, Korea bridging study [50 mg], and EMPOWUR trial [75 mg]) for four voiding‐diary endpoints: micturitions/day, urgency episodes/day, urgency urinary incontinence (UUI) episodes/day, and voided volume (mL). For each endpoint, a Bayesian normal–normal random‐effects model estimated the pooled mean effect and between‐trial heterogeneity and calculated posterior probabilities of benefit and of exceeding thresholds predefined in this analysis. Results: Pooled mean effects (95% credible intervals) favored vibegron across all four voiding‐diary endpoints: micturitions/day (−0.76, −1.33 to −0.28), urgency episodes/day (−0.69, −1.35 to −0.22), UUI episodes/day (−0.44, −0.93 to −0.03), and voided volume (+24.09 mL, 15.78–32.51). The posterior probabilities of benefit were 99.5%, 99.3%, 98.0%, and > 99.9%, respectively. The probabilities of exceeding thresholds were as follows: for micturitions/day, ≤ −0.5: 90.3% and ≤ −1.0: 14.2%; for urgency episodes/day, ≤ −0.5: 82.8% and ≤ −1.0: 12.7%; for UUI episodes/day, ≤ −0.3: 81.8% and ≤ −0.5: 35.4%; and for voided volume, ≥ +10 mL: 99.5%, ≥ +20 mL: 88.4%, and ≥ +30 mL: 5.8%. Conclusions: Bayesian cross‐trial synthesis demonstrates a high probability that vibegron improves key OAB voiding‐diary outcomes at Week 12. By explicitly quantifying the probability of exceeding clinically interpretable decision thresholds, this approach provides a transparent assessment of both the direction and magnitude of treatment effects, facilitating clinically interpretable decision‐making.
- 22 July 2026
- Published by Wiley in LUTS: Lower Urinary Tract Symptoms
- Vol. 18 (4) , e70083
Probabilistic Multicriteria Decision Analysis of Minimally Invasive Treatments for Benign Prostatic Obstruction: A Secondary Analysis of Network Meta‐Analysis Data
Objectives: To compare minimally invasive surgical therapies (MISTs) for benign prostatic obstruction (BPO) using probabilistic multicriteria decision analysis that integrates heterogeneous clinical outcomes under varying stakeholder priorities. Methods: This secondary analysis was derived from a published network meta‐analysis. Three treatments—monopolar transurethral resection of the prostate (mTURP), prostatic urethral lift (PUL), and water vapor thermal therapy (WVTT)—were compared across six criteria: International Prostate Symptom Score (IPSS), IPSS Quality of Life, maximum urinary flow rate ( Q max ), postvoid residual urine volume (PVR), and two domains of the Male Sexual Health Questionnaire Short Form. Treatment effects were sampled using a Monte Carlo simulation (50 000 iterations) and mapped to a 0–1 scale using clinically interpretable anchors. Five weighting scenarios produced preference probabilities and net advantages with 95% uncertainty intervals (UI). Anchor perturbation and correlation sensitivity analyses assessed robustness. Results: Under equal weights, WVTT had the highest P (best) (54.1%), followed by mTURP (25.8%) and PUL (20.1%); all pairwise UIs crossed zero. Under efficacy weights, mTURP had the highest P (best) (88.0%; net advantage vs. PUL: 0.124, 95% UI: 0.034–0.214), driven by superiority in Q max and PVR. Under sexual function weights, mTURP was rarely preferred ( P [best] < 0.1%), whereas PUL and WVTT achieved P (best) of 45.3% and 54.7%, respectively. Rankings were robust in both anchor perturbation and correlation sensitivity analyses. Conclusion: Within short‐term (3–6 month) data, MIST preference for BPO depends on clinical priorities. mTURP is favored when urodynamic outcomes are emphasized; PUL and WVTT are preferred when preservation of sexual function is prioritized. This framework supports preference‐sensitive shared decision‐making, although the findings are provisional pending long‐term data.
- 22 July 2026
- Published by Wiley in LUTS: Lower Urinary Tract Symptoms
- Vol. 18 (4) , e70083
Probabilistic Multicriteria Decision Analysis of Minimally Invasive Treatments for Benign Prostatic Obstruction: A Secondary Analysis of Network Meta‐Analysis Data
Objectives: To compare minimally invasive surgical therapies (MISTs) for benign prostatic obstruction (BPO) using probabilistic multicriteria decision analysis that integrates heterogeneous clinical outcomes under varying stakeholder priorities. Methods: This secondary analysis was derived from a published network meta‐analysis. Three treatments—monopolar transurethral resection of the prostate (mTURP), prostatic urethral lift (PUL), and water vapor thermal therapy (WVTT)—were compared across six criteria: International Prostate Symptom Score (IPSS), IPSS Quality of Life, maximum urinary flow rate ( Q max ), postvoid residual urine volume (PVR), and two domains of the Male Sexual Health Questionnaire Short Form. Treatment effects were sampled using a Monte Carlo simulation (50 000 iterations) and mapped to a 0–1 scale using clinically interpretable anchors. Five weighting scenarios produced preference probabilities and net advantages with 95% uncertainty intervals (UI). Anchor perturbation and correlation sensitivity analyses assessed robustness. Results: Under equal weights, WVTT had the highest P (best) (54.1%), followed by mTURP (25.8%) and PUL (20.1%); all pairwise UIs crossed zero. Under efficacy weights, mTURP had the highest P (best) (88.0%; net advantage vs. PUL: 0.124, 95% UI: 0.034–0.214), driven by superiority in Q max and PVR. Under sexual function weights, mTURP was rarely preferred ( P [best] < 0.1%), whereas PUL and WVTT achieved P (best) of 45.3% and 54.7%, respectively. Rankings were robust in both anchor perturbation and correlation sensitivity analyses. Conclusion: Within short‐term (3–6 month) data, MIST preference for BPO depends on clinical priorities. mTURP is favored when urodynamic outcomes are emphasized; PUL and WVTT are preferred when preservation of sexual function is prioritized. This framework supports preference‐sensitive shared decision‐making, although the findings are provisional pending long‐term data.
- Open Access
- 13 May 2026
- Published by AVES YAYINCILIK A.Ş. in Urology Research and Practice
- Vol. 52, 1-8
Radical Nephroureterectomy in the Very Elderly: A Single-Center Experience of Patients Aged ≥85 Years
Objective: The incidence of upper tract urothelial carcinoma is increasing with population aging, yet evidence regarding radical nephroureterectomy (RNU) in very elderly patients is limited. This study evaluated perioperative outcomes, complications, and oncological results of RNU in patients aged ≥85 years compared with younger counterparts. Methods: A total of 305 patients who underwent RNU between April 2003 and December 2024 at a tertiary institution were retrospectively reviewed. After excluding those with incomplete data (n = 4), non-urothelial histology (n = 8), or undeterminable pathology (n = 9), 284 patients were eligible. Group A included 24 patients aged ≥85 years, range 85-94 years, and group B included 260 patients .05). Median laparoscopic operative time was shorter in group A (206 vs. 235 minutes, P = .029). Estimated blood loss, transfusion, and complication rates (10.6% overall; major 2.2%) did not differ (all P > .05). Pathological outcomes were comparable (all P > .05). Adjuvant therapy was less frequent in group A (0% vs. 21.2%, P = .006). Follow-up was 16.3 vs. 35.2, with no differences in survival (all P > .05). The RMST showed shorter survival in group A. Conclusion: The RNU appears feasible in carefully selected patients aged ≥85 years, with perioperative and oncological outcomes broadly comparable to those of younger patients. Chronological age alone should not contraindicate surgery. Restricted mean survival time offers complementary insights into survival estimation in this high-risk population. Cite this article as: Gozu S, Yajima S, Okumura G, et al. Radical nephroureterectomy in the very elderly: A single-center experience of patients aged ≥85 years. Urol Res Pract. 2026, 52, 0125, doi: 10.5152/tud.2026.25125.
- 13 May 2026
- Published by AVES YAYINCILIK A.Ş. in Urology Research and Practice
- Vol. 52, 1-8
Open AccessRadical Nephroureterectomy in the Very Elderly: A Single-Center Experience of Patients Aged ≥85 Years
Objective: The incidence of upper tract urothelial carcinoma is increasing with population aging, yet evidence regarding radical nephroureterectomy (RNU) in very elderly patients is limited. This study evaluated perioperative outcomes, complications, and oncological results of RNU in patients aged ≥85 years compared with younger counterparts. Methods: A total of 305 patients who underwent RNU between April 2003 and December 2024 at a tertiary institution were retrospectively reviewed. After excluding those with incomplete data (n = 4), non-urothelial histology (n = 8), or undeterminable pathology (n = 9), 284 patients were eligible. Group A included 24 patients aged ≥85 years, range 85-94 years, and group B included 260 patients .05). Median laparoscopic operative time was shorter in group A (206 vs. 235 minutes, P = .029). Estimated blood loss, transfusion, and complication rates (10.6% overall; major 2.2%) did not differ (all P > .05). Pathological outcomes were comparable (all P > .05). Adjuvant therapy was less frequent in group A (0% vs. 21.2%, P = .006). Follow-up was 16.3 vs. 35.2, with no differences in survival (all P > .05). The RMST showed shorter survival in group A. Conclusion: The RNU appears feasible in carefully selected patients aged ≥85 years, with perioperative and oncological outcomes broadly comparable to those of younger patients. Chronological age alone should not contraindicate surgery. Restricted mean survival time offers complementary insights into survival estimation in this high-risk population. Cite this article as: Gozu S, Yajima S, Okumura G, et al. Radical nephroureterectomy in the very elderly: A single-center experience of patients aged ≥85 years. Urol Res Pract. 2026, 52, 0125, doi: 10.5152/tud.2026.25125.
- 1 April 2026
- Published by American Society of Clinical Oncology (ASCO) in JCO Clinical Cancer Informatics
- Vol. 10 (2) , e2500307
Bayesian Methods for Subgroup Efficacy and Safety: Application to Japanese Patients in JAVELIN Renal 101
PURPOSE: JAVELIN Renal 101 revealed that avelumab plus axitinib improved progression-free survival (PFS) compared with sunitinib in advanced renal cell carcinoma. However, Japanese subgroup estimates were imprecise. In this study, we evaluated how Bayesian borrowing assumptions translate into posterior probabilities for this subgroup. PATIENTS AND METHODS: Using published summary data from JAVELIN Renal 101, we modeled PFS on the log hazard-ratio scale with a normal-normal framework, comparing a weakly informative neutral prior with informative borrowing priors centered on the global final estimate (with sensitivity to the third interim estimate). Outputs were posterior HRs, 95% credible intervals (CrIs), P (hazard ratio [HR] P (HR < 0.8). Sensitivity analyses evaluated alternative borrowing specifications. Adverse events (AEs) were assessed with a no-borrowing beta-binomial framework using noninformative Jeffreys priors for Japanese and global data sets, reporting Japanese posterior means, 95% CrIs, and probabilities of enrichment for any grade and grade ≥3. RESULTS: Under the neutral prior, evidence for PFS benefit in the Japanese subgroup was moderate ( P [HR < 1] = .83; P [HR < 0.8] = .64), whereas informative borrowing priors yielded substantially higher probabilities. Borrowing in PD-L1 + Japanese patients narrowed CrIs while preserving the favorable direction of effect. Any-grade AEs in Japanese patients were most often enriched in hepatic/laboratory, thyroid, infusion-related, and hand-foot domains. For grade ≥3, enrichment mainly involved hepatic/laboratory abnormalities, while rare severe events yielded imprecise posteriors. CONCLUSION: A paired Bayesian strategy, graded priors for efficacy and no-borrowing priors for safety, produced transparent posterior probability summaries for the Japanese subgroup. This framework illustrates how borrowing can narrow uncertainty when exchangeability is plausible, while clarifying toxicity domains that may warrant closer monitoring, using published trial data.
- 1 April 2026
- Published by American Society of Clinical Oncology (ASCO) in JCO Clinical Cancer Informatics
- Vol. 10 (2) , e2500307
Bayesian Methods for Subgroup Efficacy and Safety: Application to Japanese Patients in JAVELIN Renal 101
PURPOSE: JAVELIN Renal 101 revealed that avelumab plus axitinib improved progression-free survival (PFS) compared with sunitinib in advanced renal cell carcinoma. However, Japanese subgroup estimates were imprecise. In this study, we evaluated how Bayesian borrowing assumptions translate into posterior probabilities for this subgroup. PATIENTS AND METHODS: Using published summary data from JAVELIN Renal 101, we modeled PFS on the log hazard-ratio scale with a normal-normal framework, comparing a weakly informative neutral prior with informative borrowing priors centered on the global final estimate (with sensitivity to the third interim estimate). Outputs were posterior HRs, 95% credible intervals (CrIs), P (hazard ratio [HR] P (HR < 0.8). Sensitivity analyses evaluated alternative borrowing specifications. Adverse events (AEs) were assessed with a no-borrowing beta-binomial framework using noninformative Jeffreys priors for Japanese and global data sets, reporting Japanese posterior means, 95% CrIs, and probabilities of enrichment for any grade and grade ≥3. RESULTS: Under the neutral prior, evidence for PFS benefit in the Japanese subgroup was moderate ( P [HR < 1] = .83; P [HR < 0.8] = .64), whereas informative borrowing priors yielded substantially higher probabilities. Borrowing in PD-L1 + Japanese patients narrowed CrIs while preserving the favorable direction of effect. Any-grade AEs in Japanese patients were most often enriched in hepatic/laboratory, thyroid, infusion-related, and hand-foot domains. For grade ≥3, enrichment mainly involved hepatic/laboratory abnormalities, while rare severe events yielded imprecise posteriors. CONCLUSION: A paired Bayesian strategy, graded priors for efficacy and no-borrowing priors for safety, produced transparent posterior probability summaries for the Japanese subgroup. This framework illustrates how borrowing can narrow uncertainty when exchangeability is plausible, while clarifying toxicity domains that may warrant closer monitoring, using published trial data.