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  • 1
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 33, No. 7_suppl ( 2015-03-01), p. 399-399
    Abstract: 399 Background: By definition, primary adenocarcinoma of the bladder (PAB) is a malignant neoplasm derived from urothelium of the bladder showing histologically pure glandular differentiation. Because of its rarity, role of chemotherapy for metastatic adenocarcinoma of bladder is still questionable. Therefore, we performed a retrospective analysis of the clinical features and chemotherapy outcomes of metastatic PAB to evaluate the clinical findings at presentation, overall survival (OS) and progression-free survival (PFS) and prognostic factors. Methods: Eligible patients for this retrospective analysis were initially diagnosed with adenocarcinoma and presented with a clinically no other primary site of origin. The collected data included age, gender, performance status, stage, hemoglobin, albumin, initial date of diagnosis, treatment modality utilized, response to treatment, presence of relapse, last status of patient, and last date of follow-up. Results: We retrospectively reviewed 29 patients who treated with chemotherapy as metastatic PAB at 10 Korean medical institutions from 2004 to 2014.The median age of patients was 58 years (range, 17 to 78 years) and 51.7% of the patients were female. Fifteen patients were urachal adenocarcinoma. Of 27 symptomatic patients, 22 experienced gross hematuria. Ten patients had two or more metastatic sites of the lungs (51.7%), peritoneum (41.4%), and ovary (20.7%), as the most common sites. Twelve patients were treated with 5-FU based chemotherapy, 5 were gemcitabine based, 3 were taxane and adriamycin based, and others. 13 of them achieved CR (10.3%) or PR (34.5%). Median PFS and OS for all patients were 10.6 months (95% confidence interval [CI], 9.5 to 11.6 months) and 24.5 months (95% CI, 1.2 to 47.8 months), respectively. In the prognostic factor analysis, the cases of urachal adenocarcinoma had worse tendency in PFS and OS (p=0.024 and P=0.046, respectively). Conclusions: Metastatic Despite most of chemotherapy, PFS and OS were short especially in urachal carcinoma, however, there were some long-term survivors, therefore, additional research on the predictive markers of several clinical, pathological differences and their treatments will be needed.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2015
    detail.hit.zdb_id: 2005181-5
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  • 2
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 4_suppl ( 2023-02-01), p. 347-347
    Abstract: 347 Background: Zanidatamab (zani) is an anti-HER2 bispecific antibody against ECD4 and ECD2 with demonstrated activity and tolerability in a range of HER2-expressing cancers. This Phase (Ph) 2 study (NCT03929666) evaluates zani in combination with chemotherapy (chemo) as first-line treatment for patients (pts) with advanced HER2-expressing mGEA. Methods: Eligible pts for this ongoing, open-label study had not received any prior systemic therapy for mGEA. Pts received zani + physician’s choice of multi-agent chemo (mFOLFOX6, CAPOX, or FP). Antidiarrheal prophylaxis for cycle 1 was added after the first 25 pts were treated. Following demonstration of tolerability of the regimens in an initial safety cohort, the primary study objective was to evaluate antitumor activity. Results: Pts were enrolled between Aug 29, 2019 and Feb 18, 2022 with a data cutoff of July 28, 2022 (N=46 pts; zani + mFOLFOX6 [24], zani + CAPOX [20] , or zani + FP [2]). Median age was 58 yrs; 85% male; 42 pts (91%) had HER2+ tumors (IHC 3+ or 2+ with ISH-positivity) based on central testing. Median duration of fo llow-up among all 46 pts was 21.5 months (mo) and 20 pts (43%) remain on treatment. In 38 response-evaluable pts with HER2+ tumors, confirmed objective response rate (cORR) was 79% (95% CI: 63-90%) and disease control rate was 92% (95% CI: 79-98%); 3 pts achieved complete response. Median duration of response (DOR) was 20.4 mo (95% CI: 6.8-not estimable [NE]), with 57% (17/30) pts having an ongoing response at data cut-off (1 pt has ongoing response 〉 29 months). In all 42 pts with HER2+ tumors, median progression-free survival (PFS) was 12.5 mo (95% CI: 7.1-NE) and median overall survival (OS) was not yet reached. Survival rate at 18 mo was estimated to be 87.3%. The most common (≥25% pts) treatment-related (zani and/or chemo) adverse events (TRAE) in all pts were diarrhea, nausea, peripheral sensory neuropathy, decreased appetite, fatigue, vomiting, and hypokalemia. Diarrhea was the most common Gr3+ TRAE, lasting a median (interquartile range) of 3 (2-5) days, with the majority of events occurring in cycle 1; incidence of all Gr3+ events was 56% in 25 pts who did not receive prophylaxis and 14% in 21 pts who did. There were no treatment-related deaths. Conclusions: In pts with HER2+ mGEA, zani + chemo is a highly active treatment regimen with a manageable safety profile. This maturing data set demonstrates durable disease control with encouraging cORR, DOR, PFS and OS results. A global Ph 3 study (HERIZON-GEA-01; NCT05152147) evaluating zani in combination with physician’s choice of standard chemo with or without the PD-1 inhibitor, tislelizumab, for first-line treatment of advanced HER2+ mGEA is currently enrolling. Clinical trial information: NCT03929666 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
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