scholarly journals A Real-World Comparative Analysis of Lenvatinib and Sorafenib as a Salvage Therapy for Transarterial Treatments in Unresectable HCC

2020 ◽  
Vol 9 (12) ◽  
pp. 4121
Author(s):  
Jaejun Lee ◽  
Pil Soo Sung ◽  
Hyun Yang ◽  
Soon Kyu Lee ◽  
Hee Chul Nam ◽  
...  
Keyword(s):  
Confidence Interval ◽  
Real World ◽  
Salvage Therapy ◽  
Objective Response ◽  
Progression Free Survival ◽  
Hazard Ratio ◽  
Rank Test ◽  
Multikinase Inhibitor ◽  
Free Survival ◽  
Sorafenib Group

Background/Aims: Lenvatinib was recently approved as a first-line oral multikinase inhibitor for unresectable hepatocellular carcinoma (HCC). In this study, we aimed to compare the efficacy and safety of lenvatinib and sorafenib for the treatment of unresectable HCC in patients with prior failure of transarterial treatment. Methods: Between January 2019 and September 2020, 98 unresectable HCC patients treated with lenvatinib or sorafenib as salvage therapy were enrolled from five Korean university-affiliated hospitals. Progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and disease control rate were calculated to assess the antitumor response. Results: A total of 43 and 55 patients were treated with lenvatinib and sorafenib, respectively, as salvage therapy after the failure of transarterial treatments. The median PFS was 4.97 months in the lenvatinib group and 2.47 months in the sorafenib group (p = 0.001, log-rank test). The ORR was significantly higher in the lenvatinib group (25.6%) than in the sorafenib group (3.6%, p = 0.002). Use of lenvatinib over sorafenib (hazard ratio: 0.359, 95% confidence interval: 0.203–0.635, p < 0.001) was the most significant factor for a favorable PFS after the failure of transarterial treatments in all enrolled patients. For favorable OS, achieving objective response was the significant factor (hazard ratio 0.356, 95% confidence interval: 0.132–0.957, p = 0.041). There were no significant differences in the safety profile between the two groups. Conclusions: In this real-world study, lenvatinib was demonstrated to be more efficacious than sorafenib as a salvage therapy for transarterial treatments in unresectable HCC.

Effect of comorbidities/comedications on treatment outcomes with sunitinib in patients (pts) with metastatic renal cell carcinoma (mRCC): Subgroup analyses from the STAR-TOR registry.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 631-631
Author(s):  
Stephan Bernhardt ◽  
Marcus Hubbe ◽  
Michael Rink ◽  
Lothar Bergmann ◽  
Martin Boegemann ◽  
...  
Keyword(s):  
Treatment Outcomes ◽  
Real World ◽  
Objective Response ◽  
Progression Free Survival ◽  
Rank Test ◽  
Free Survival ◽  
Exact Test ◽  
Sunitinib Treatment ◽  
Kaplan Meier ◽  
Cutoff Date

631 Background: Sunitinib remains an important treatment option for mRCC, but the effect of comorbidities/comedications on sunitinib treatment outcomes have not been fully explored. Methods: Data were collated from STAR-TOR, an ongoing real-world registry. Cutoff date for analysis was 19 June 2019. This subgroup analysis assessed the presence or absence of hypertension (HTN), and the use or non-use of statins and proton pump inhibitors (PPIs), determined at the time of entry to the registry. Treatment endpoints were overall survival (OS), progression-free survival (PFS) and objective response rate (ORR). OS and PFS were analyzed by Kaplan-Meier methods. Differences within subgroups were tested using Log-rank test for OS and PFS, and Fisher’s exact test for ORR. Results: 557 sunitinib-treated pts were analyzed; 366 had HTN and 191 did not, 130 used statins and 427 did not, and 165 used PPIs and 392 did not. Median (m) OS (95% confidence intervals) was similar in pts with and without HTN (25.4 [21.1, 31.5] vs 21.5 [15.2, 28.0] months; p = 0.215). mPFS (8.0 [6.5, 9.9] vs 6.3 [5.4, 8.2] months; p = 0.140) and ORR (31.2% vs 30.9%; p = 1.000) were also similar in pts with and without HTN. mOS was similar in pts who used statins vs those who did not (27.8 [20.2, 35.4] vs 24.0 [19.4, 27.3] months; p = 0.884), while mPFS was significantly longer in pts who used statins (9.4 [6.5, 13.6] vs 6.9 [5.7, 8.2] months; p = 0.044). ORR was 37.8% vs 29.0% in pts who did and did not use statins (p = 0.072). mOS was significantly shorter in pts who used PPIs vs those who did not (20.2 [14.9, 28.3] vs 25.7 [22.7, 33.0] months; p = 0.021). mPFS (5.8 [4.6, 8.2] vs 8.0 [6.5, 9.8] months; p = 0.091) and ORR (26.6% vs 33.0%; p = 0.177) were similar in pts who did and did not use PPIs. Conclusions: In sunitinib-treated pts with mRCC in a real-world registry, mPFS was significantly longer and there was a trend toward better ORR in pts who used statins, whereas mOS was significantly shorter and there was a trend toward shorter mPFS in pts who used PPIs. Common comedications may affect sunitinib treatment outcomes in pts with mRCC.

scholarly journals Outcomes in Clinically Relevant Patient Subgroups From the EMBRACA Study: Talazoparib vs Physician’s Choice Standard-of-Care Chemotherapy

2019 ◽  
Vol 4 (1) ◽  
Author(s):  
Hope S Rugo ◽  
Johannes Ettl ◽  
Sara A Hurvitz ◽  
Anthony Gonçalves ◽  
Kyung-Hun Lee ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Confidence Interval ◽  
Clinical Benefit ◽  
Odds Ratio ◽  
Objective Response ◽  
Progression Free Survival ◽  
Hazard Ratio ◽  
Free Survival ◽  
Duration Of Response ◽  
Patient Subgroups

Abstract Background Talazoparib is a poly(adenosine diphosphate-ribose) polymerase inhibitor that causes death in cells with breast cancer susceptibility gene 1 or 2 (BRCA1/2) mutations. Methods EMBRACA (NCT01945775) was a randomized phase III study comparing efficacy, safety, and patient-reported outcomes (PROs) of talazoparib (1 mg) with physician’s choice of chemotherapy (PCT: capecitabine, eribulin, gemcitabine, vinorelbine) in locally advanced or metastatic breast cancer with a germline BRCA1/2 (gBRCA1/2) mutation. Prespecified patient subgroups were analyzed for progression-free survival, objective response, clinical benefit, duration of response, and safety. PROs were evaluated in hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) or triple-negative breast cancer (TNBC) subgroups. Results Of 431 patients, 287 were randomly assigned to talazoparib and 144 to PCT. Prespecified subgroup analyses showed prolonged progression-free survival with talazoparib (HR+/HER2−: hazard ratio = 0.47, 95% confidence interval = 0.32 to 0.71; TNBC: hazard ratio = 0.60, 95% confidence interval = 0.41 to 0.87) and greater objective response rate (odds ratio = 1.97 to 11.89), clinical benefit rate (odds ratio = 2.05 to 7.77), and duration of response with talazoparib in all subgroups. PROs in HR+/HER2− and TNBC subgroups showed consistent overall improvement and delay in time to definitive clinically meaningful deterioration with talazoparib vs PCT. Across subgroups, common adverse events included anemia, fatigue, and nausea with talazoparib and neutropenia, fatigue, and nausea with PCT. Seven patients (2.4%) receiving talazoparib had grade II alopecia and 22.7% had grade I alopecia. Conclusions Across all patient subgroups with gBRCA-mutated advanced breast cancer, talazoparib demonstrated clinically significant superiority in outcomes compared with PCT.

Retrospective cohort analysis of real-world clinical outcomes in nonmetastatic (M0) castration-resistant prostate cancer (CRPC) treated with novel androgen receptor pathway inhibitors (ARPI).

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 51-51
Author(s):  
Richard Gagnon ◽  
Nimira S. Alimohamed ◽  
Alexander Watson ◽  
Eugene Batuyong ◽  
Alyssa Chow ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Outcomes ◽  
Real World ◽  
Retrospective Cohort ◽  
Cohort Analysis ◽  
Progression Free Survival ◽  
Rank Test ◽  
Castration Resistant Prostate Cancer ◽  
Survival Times ◽  
Free Survival

51 Background: The landscape of M0 CRPC has changed with the recent demonstration of metastasis-free survival (MFS) and overall survival (OS) improvements with the use of ARPIs in clinical trial settings. However, the extrapolation of this data to clinical practice is limited by strict exclusion criteria in these trials, including prior or concurrent malignancy, cardiovascular disease, or hypertension. The purpose of this study was to assess real-world outcomes in patients with M0 CRPC treated with ARPIs compared to historical controls. Methods: We designed a retrospective cohort study with the inclusion of patients in Alberta, Canada diagnosed with M0 CRPC between 2001-2020. Via chart review, we identified baseline characteristics, potential confounders, treatment details, and clinical outcomes. The primary outcome of interest was MFS. Secondary outcomes included: second progression-free survival (PFS2) and OS. Median survival times were measured using the Kaplan-Meier method and the log-rank test was used for comparison of outcomes based on ARPI exposure. Cox proportional hazard regression models were used to calculate hazard ratios (HR) accounting for impact of PSA doubling time (PSADT), use of osteoclast inhibiting agents, and presence of pelvic lymphadenopathy. Results: We identified 211 patients across multiple centres in Alberta with M0 CRPC, with 54 having received apalutamide (40/54), enzalutamide (7/54), or darolutamide (7/54). Median age at M0 CRPC diagnosis was 74 years; median PSADT was 4.4 months; and 19% of patients (40/211) had pelvic lymphadenopathy at diagnosis. Median MFS in patients treated with ARPIs was 47.5 months compared to 20.6 months in those not treated with ARPIs (HR, 0.23; 95% confidence interval [CI], 0.11-0.49; p < 0.001). Median PFS2 in ARPI treated patients was 66.3 months compared with 35.6 months (HR, 0.40; 95% CI, 0.18-0.87; p = 0.022). Median OS for patients treated with ARPI was not reached. Conclusions: Given the older age of men with advanced prostate cancer, real-world outcomes that include patients with comorbidities are important adjuncts to the interpretation of clinical trials exploring the benefit of novel therapeutics. Here, we demonstrate that in a real-world, unselected population of men with M0 CRPC, apalutamide, enzalutamide, and darolutamide seem to confer similar MFS and PFS2 benefits to those demonstrated in the SPARTAN, PROSPER, and ARAMIS studies. Real-world OS data remain immature and will be an important addition to these findings.

Does endometriosis have an effect on the survival of women with synchronous endometrial and ovarian cancer?

2019 ◽  
Vol 11 (4) ◽  
pp. 185-193
Author(s):  
Engin Celik ◽  
Hale Goksever Celik ◽  
Hamdullah Sozen ◽  
Semen Onder ◽  
Merve Baktiroglu ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Overall Survival ◽  
Confidence Interval ◽  
Detrimental Effect ◽  
Clear Cell ◽  
Cell Cancer ◽  
Progression Free Survival ◽  
Hazard Ratio ◽  
Free Survival ◽  
Pathological Characteristics

Purpose: Synchronous endometrial and ovarian cancer is defined as the concurrent presence of ovarian cancer with endometrial cancer. We aimed to evaluate whether there is an effect of endometriosis on progression-free survival and overall survival of women with synchronous endometrial and ovarian cancer. We also compared these findings with the patients having endometrial-only tumors and ovarian-only tumors. Methods: The patients who underwent surgery for endometrioid or clear-cell endometrial-only tumors and/or ovarian-only tumors and synchronous endometrial and ovarian cancer between 2005 and 2016 were included in this cohort study. The effect of the presence of endometriosis on progression-free survival and overall survival in these women who met the criteria was determined using statistical methods. Women were also compared regarding their demographic, clinical, and pathological characteristics. Results: A total of 176 patients were included in this study. All histology types of tumors located in endometrium or ovary were endometrioid or clear-cell cancer. Endometriosis was present in 62 patients (35.2%), whereas adenomyosis was present in 44 patients (25%). Endometriosis was diagnosed more frequently in women with ovarian-only tumors and synchronous endometrial and ovarian cancer than those with endometrial-only tumors (59.2% vs 5.7%, p < 0.001 and 45.7% vs 5.7%, p < 0.001, respectively). The patients with endometriosis showed no significantly longer progression-free survival and overall survival (hazard ratio = 1.70; 95% confidence interval = 0.48–6.03; p = 0.408 and hazard ratio = 1.67; 95% confidence interval = 0.30–9.44; p = 0.562, respectively). The presence of endometriosis was a stronger predictor for progression-free survival and overall survival comparing with the presence of adenomyosis. Conclusion: The women with synchronous endometrial and ovarian cancer should be informed that endometriosis has no detrimental effect on progression-free survival and overall survival.

Why Routine Clinical Follow-up for Patients With Early Stage Endometrial Cancer Is Not Always Necessary: A Study on Women in South Wales

2014 ◽  
Vol 24 (3) ◽  
pp. 556-563 ◽  
Author(s):  
Lilly Aung ◽  
Robert E.J. Howells ◽  
Kenneth C.K. Lim ◽  
Emma Hudson ◽  
Peter W. Jones
Keyword(s):  
Endometrial Cancer ◽  
Confidence Interval ◽  
Endometrial Carcinoma ◽  
Early Stage ◽  
Progression Free Survival ◽  
Disease Recurrence ◽  
Hazard Ratio ◽  
Free Survival ◽  
South Wales

ObjectiveThis study aimed to examine the existing methods of follow-up in women who have undergone treatment of early endometrial carcinoma in South Wales and to assess if they are appropriate.DesignThis study used a retrospective analysis of follow-up data.SettingThis study was performed in the Virtual Gynaecological Oncology Centre, South Wales, United Kingdom.SampleThis study sample is composed of 552 women.MethodsData regarding follow-up were collected retrospectively from patient case notes and computerized data systems. Data were analyzed using the Pearson χ2 test, Cox proportional hazard regression analysis, and Kaplan-Meier curves.Main Outcome MeasuresThis study aimed to determine whether routine follow-up was beneficial in detecting disease recurrence and whether outcome was influenced by routine follow-up.ResultsBetween January 1, 2000, and December 31, 2010, 552 women were treated for early stage endometrial carcinoma. The 5-year survival was 81%, and the 5-year progression-free survival was 77%. Of these 552 women, 81 (15%) developed a disease recurrence; the majority (61/81 [75%]) recurred within 3 years. The median survival was 35 months compared with 47 months in patients who did not develop a recurrence. Of the 81 patients, 73 (90%) were symptomatic and only 5 patients were truly asymptomatic at follow-up. The most important and significant prognostic factor was “recurrent disease” with overall survival (hazard ratio, 2.20; P < 0.001; 95% confidence interval, 1.75–2.65) and progression-free survival (hazard ratio, 2.52; P < 0.001; 95% confidence interval, 2.09–2.95). “Asymptomatic recurrence” was not an independent predictor of outcome.ConclusionsRoutine follow-up for early endometrial cancer is not beneficial for patients because most were symptomatic at the time of detection. It does not significantly improve the outcome. We propose altering the follow-up time regimen and adopting alternative follow-up strategies for women in South Wales.

scholarly journals Sorafenib-Regorafenib Sequential Therapy in Japanese Patients with Unresectable Hepatocellular Carcinoma—Relative Dose Intensity and Post-Regorafenib Therapies in Real World Practice

Cancers ◽  
2019 ◽  
Vol 11 (10) ◽  
pp. 1517 ◽  
Author(s):  
Wang ◽  
Tsuchiya ◽  
Kurosaki ◽  
Yasui ◽  
Inada ◽  
...  
Keyword(s):  
Real World ◽  
Objective Response ◽  
Dose Intensity ◽  
Progression Free Survival ◽  
Sequential Therapy ◽  
Japanese Patients ◽  
Relative Dose Intensity ◽  
Free Survival ◽  
Median Total Dose ◽  
Clinically Significant

Background: We aimed to explore the relative dose intensity (RDI) and post-regorafenib treatments in regorafenib therapy. Methods: The medical records of 38 patients treated with regorafenib between July 2017 and June 2019 at our institution were collected. The RDI of regorafenib for the first month (1M-RDI) was calculated. Results: The overall survival (OS) and progression-free survival (PFS) were 12.4 and 3.7 months. The objective response rate and disease control rate were 13.2% and 71.1%. The median total dose of regorafenib in the first month was 2080 mg (240–3360 mg), and the median 1M-RDI was 61.9% (7.1%–100%). Patients with 1M-RDI ≥ 50% showed significantly longer OS and PFS than patients with 1M-RDI < 50% (HR 0.19, 95% CI 0.08–0.48, p = 0.0004 and HR 0.2, 95% CI 0.08–0.52, p = 0.0008). A 1M-RDI ≥ 50% (HR 0.18, 95% CI 0.06–0.55, p = 0.002) and hand–foot skin reaction (HR 0.03, 95% CI 0.008–0.16, p < 0.0001) were independently associated with OS. Post-regorafenib therapies were performed in 19 (86.4%) of 22 patients who had stopped regorafenib due to disease progression. Conclusion: A 1M-RDI ≥ 50% is clinically significant. Post-regorafenib therapies are commonly performed in real-world practice.

scholarly journals Anlotinib Alone or in Combination With Temozolomide in the Treatment of Recurrent High-Grade Glioma: A Retrospective Analysis

2021 ◽  
Vol 12 ◽  
Author(s):  
Qunying Yang ◽  
Chengcheng Guo ◽  
Xiaoping Lin ◽  
Lili Luo ◽  
Zhenqiang He ◽  
...  
Keyword(s):  
Overall Survival ◽  
Objective Response ◽  
Progression Free Survival ◽  
High Grade Glioma ◽  
Rank Test ◽  
Cancer Center ◽  
High Grade ◽  
Karnofsky Score ◽  
Free Survival ◽  
Grade 3

Background: Anlotinib is a multi-target anti-angiogenic agent. This retrospective study aimed to evaluate the efficacy and safety of anlotinib alone or in combination with temozolomide for the treatment of recurrent high-grade glioma.Materials and Methods: The clinical data of patients with recurrent high-grade glioma treated with anlotinib alone or in combination with temozolomide in our cancer center were collected and analyzed. Treatment response was evaluated according to the response assessment for neuro-oncology criteria. Progression-free survival, progression-free survival at 6 months, overall survival, and overall survival at 12 months were evaluated by Kaplan–Meier method and compared by log-rank test.Results: Between August 2019 and December 2020, 31 patients with recurrent high-grade glioma (21 of grade 4 and 10 of grade 3) were enrolled in this study. Seventeen patients received anlotinib alone and 14 received anlotinib plus temozolomide. All patients were heavily treated, the median lines of previous treatments were 2, and the median Karnofsky score was 60. At the data cutoff date, the median progression-free survival was 4.5 months and the progression-free survival at 6 months was 43.5%. The median overall survival was 7.7 months, and the overall survival at 12 months was 26.7%. The progression-free survival at 6 months and the overall survival at 12 months for 21 patients with grade 4 glioma was 40.2 and 27.9%, respectively. The tumor objective response rate was 41.9% in all patients and 33.3% in patients with grade 4 glioma. No grade 3 or worse treatment-related adverse events were recorded during the treatment.Conclusion: Anlotinib alone or in combination with temozolomide showed encouraging efficacy and favorable tolerability in patients with recurrent high-grade glioma who had been heavily treated.

Comparison of efficacy and toxicity of bevacizumab in combination with chemotherapy in the first, second, and third or higher line of treatment for metastatic colorectal carcinoma (mCRC): Data from the Czech multi-institutional registry.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e14622-e14622
Author(s):  
Igor Kiss ◽  
Zbynek Bortlicek ◽  
Bohuslav Melichar ◽  
Alexandr Poprach ◽  
Jana Halamkova ◽  
...  
Keyword(s):  
Adverse Events ◽  
Objective Response ◽  
Progression Free Survival ◽  
National Registry ◽  
Rank Test ◽  
Test Results ◽  
Clinical Registry ◽  
Free Survival ◽  
Kaplan Meier ◽  
Analysis Survival

e14622 Background: Data from the Czech national registry of patients treated with targeted therapies for mCRC were analyzed retrospectively to compare treatment outcomes for bevacizumab in combination with chemotherapy in the 1st, 2nd and 3rd line of treatment. Methods: The database was launched in 2005 as a clinical registry of patients with mCRC treated with bevacizumab. Epidemiological and clinical data are entered by all Czech comprehensive cancer centers administering targeted therapy. In total, 4487 mCRC patients who received bevacizumab combined with chemotherapy in either 1st line (n=3990, 88.9%), 2nd line (n=386, 8.6%), or 3rd and higher line (n=111, 2.5%) had evaluable data and were included in the present analysis. Survival was calculated using the Kaplan-Meier method, and the differences were assessed using the log-rank test. Results: Statistically significant differences were observed in the efficacy of combination chemotherapy with bevacizumab between the treatment lines. The objective response rate (ORR) in the 1st, 2nd, and 3rd/higher line was 42.9%, 34.0% and 8.3%; (p<0.001) respectively. Similarly, in the 1st, 2nd, and 3rd/higher line median progression free survival (mPFS) was 11.3 months (95% CI 11.0-11.7 months), 9.5 months (95% CI 8.2-10.9 months) , and 7.3 months (95% CI 5.9-8.7 months; p<0.001), and median overall survival (mOS) was 28.4 months (95% CI 27.1-29.8 months), 25.9 months (95% CI 19.4-32.4 months), and 15.0 months (95% CI 10.7-19.3 months; p<0.001), respectively. The spectrum of the most common adverse events was comparable in the 1st, 2nd, or 3rd/higher line, and incidence of adverse events was similar at 11.6%, 8.8% and 8.1%, respectively. Conclusions: The efficacy of bevacizumab in combination with chemotherapy decreased when administered in later lines of treatment for mCRC while the incidence and spectrum of toxicities remains unchanged.

Use of Aggressive Surveillance for Locoregional Endometrial Cancer After Local Therapy

2018 ◽  
Vol 28 (7) ◽  
pp. 1264-1270
Author(s):  
Pratyusha Yalamanchi ◽  
Jacob E. Shabason ◽  
Xiaochen Zhang ◽  
Emily M. Ko ◽  
Lilie L. Lin
Keyword(s):  
Overall Survival ◽  
Confidence Interval ◽  
Endometrial Carcinoma ◽  
Progression Free Survival ◽  
Hazard Ratio ◽  
Serous Carcinoma ◽  
Trimodality Therapy ◽  
Free Survival ◽  
Routine Surveillance ◽  
Surveillance Imaging

Purpose/ObjectivesCurrent guidelines do not recommend routine surveillance imaging as part of follow-up care for patients treated for locoregional endometrial carcinoma. This study seeks to determine the potential benefit of routine surveillance imaging by evaluating outcomes of patients whose recurrences were detected on routine surveillance compared to those whose recurrences were identified after presenting with symptoms.Materials/MethodsWe conducted a retrospective review of patients who developed recurrence after surgical treatment, with or without adjuvant therapy, for locoregional endometrial carcinoma. A total of 149 patients were identified with adequate clinical information regarding the recurrence. Cox proportional hazards regression analysis was used to estimate overall survival and progression-free survival.ResultsThe median age of patients at diagnosis was 69.2 years (range, 38.0-99.5 years). Initial stages included stage I, 49.7%; stage II, 10.1%; stage III, 38.3%; and stage IV, 1.3%. Histologic diagnoses included endometrioid adenocarcinoma, 48.3%; and other diagnoses (including papillary serous carcinoma, clear cell carcinoma, and carcinosarcoma), 51.7%. Patients were initially treated with a variety of therapies: surgery alone in 20.8%, surgery and radiation in 25.5%, surgery and chemotherapy in 12.1%, and trimodality therapy in 41.6%. Sites of recurrence included 20.8% vaginal, 14.8% pelvic and 64.4% distant sites. Recurrences were detected asymptomatically in 86 patients (57.7%) and symptomatically in 63 patients (42.3%). Of those detected asymptomatically, 80.2% were detected by imaging. Overall, when comparing symptomatic versus asymptomatic recurrences, there was no difference in overall survival (hazard ratio, 1.24; 95% confidence interval, 0.84-1.83; P = 0.29) or progression-free survival (hazard ratio, 1.14; 95% confidence interval, 0.77-1.70; P = 0.52).ConclusionsPatients who develop asymptomatic recurrences of their endometrial carcinoma do not seem to have a better prognosis than those who present with symptomatic recurrences. Thus, these results do not support routine imaging surveillance for patients treated for locoregional endometrial carcinoma. Further prospective evaluation is needed.

Randomized Phase III Trial of Gemcitabine and Cisplatin With Bevacizumab or Placebo in Patients With Advanced Urothelial Carcinoma: Results of CALGB 90601 (Alliance)

2021 ◽  
pp. JCO.21.00286
Author(s):  
Jonathan E. Rosenberg ◽  
Karla A. Ballman ◽  
Susan Halabi ◽  
Pamela J. Atherton ◽  
Amir Mortazavi ◽  
...  
Keyword(s):  
Urothelial Carcinoma ◽  
Controlled Trial ◽  
Objective Response ◽  
Progression Free Survival ◽  
Primary Objective ◽  
Hazard Ratio ◽  
Phase Iii ◽  
Free Survival ◽  
Metastatic Urothelial Carcinoma ◽  
Gemcitabine And Cisplatin

PURPOSE The combination of gemcitabine and cisplatin (GC) is a standard therapy for metastatic urothelial carcinoma. Based on data that angiogenesis plays a role in urothelial carcinoma growth and progression, a randomized placebo-controlled trial was performed with the primary objective of testing whether patients treated with GC and bevacizumab (GCB) have superior overall survival (OS) than patients treated with GC and placebo (GCP). PATIENTS AND METHODS Between July 2009 and December 2014, 506 patients with metastatic urothelial carcinoma without prior chemotherapy for metastatic disease and no neoadjuvant or adjuvant chemotherapy within 12 months were randomly assigned to receive either GCB or GCP. The primary end point was OS, with secondary end points of progression-free survival, objective response, and toxicity. RESULTS With a median follow-up of 76.3 months among alive patients, the median OS was 14.5 months for patients treated with GCB and 14.3 months for patients treated with GCP (hazard ratio for death = 0.87; 95% CI, 0.72 to 1.05; two-sided stratified log-rank P = .14). The median progression-free survival was 8.0 months for GCB and 6.7 months for GCP (hazard ratio = 0.77; 95% CI, 0.63 to 0.95; P = .016). The proportion of patients with grade 3 or greater adverse events did not differ significantly between both arms, although increased bevacizumab-related toxicities such as hypertension and proteinuria occurred in the bevacizumab-treated arm. CONCLUSION The addition of bevacizumab to GC did not result in improved OS. The observed median OS of about 14 months is consistent with prior phase III trials of cisplatin-based chemotherapy.

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