Paclitaxel, carboplatin, and capecitabine (TCX) with and without radiation in locally advanced and metastatic distal esophageal and esophagogastric junction cancer: A single-center retrospective review.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 197-197
Author(s):  
Peter Joel Hosein ◽  
Neha Ray ◽  
Lowell Brian Anthony ◽  
Ching-Wei David Tzeng ◽  
Mahesh R. Kudrimoti ◽  
...  
Keyword(s):  
Median Survival ◽  
Retrospective Review ◽  
Esophagogastric Junction ◽  
Locally Advanced ◽  
Toxicity Profile ◽  
Single Center ◽  
First Line ◽  
General Acceptance ◽  
First Line Therapy ◽  
Kaplan Meier

197 Background: Toxicities of the active triple-drug DCF regimen (docetaxel, cisplatin and 5-FU) in gastric cancer limit its broad use and general acceptance as first-line therapy. To improve the toxicity profile of triple-drug therapy, distal esophageal and esophagogastric junction (DE-EGJ) poorly differentiated and moderately differentiated adenocarcinoma patients were treated with TCX. This single-center retrospective review is reported for patients treated between 2005 and 2013. Methods: Patients with DE-EGJ adenocarcinoma were treated with capecitabine (850 mg/m2 5 out of 7 or 14 out of 21 days), carboplatin (AUC 5) and paclitaxel (175 mg/m2) every 3 weeks. Those with locally advanced disease received concomitant radiation therapy (50.4 Gy using 3D approach) during the first 2 cycles. Dose reductions (25-50%), delay of therapy and hospitalizations for disease and treatment-related Grades 3/4 toxicities were recorded. Growth factors were prescribed reactively. Kaplan-Meier statistics were used for survival analyses. The institutional tumor registry data provided the historical median survival. Results: Thirty-one males and 3 females (median age 56, range 37-82) with locally advanced (N=17) and metastatic (N=17) disease were included. Median overall survivals are shown below. Two patients were admitted for neutropenic fever and 7 total hospitalizations occurred. Conclusions: A triple-drug combination first-line regimen (TCX) with and without radiation in DE-EGJ cancer is active, and associated with a manageable toxicity profile. The median survival of 15.8 months in patients with metastatic disease treated with TCX compares favorably with the DCF regimen (9.2 mos), the EOX regimen (11.2 mos) as well as institutional historical controls. Our data suggests that future prospective trials evaluating triple-drug regimens in combination with targeted therapy may be feasible in patients with esophageal and gastric adenocarcinoma. [Table: see text]

First line gemcitabine and nab-paclitaxel chemotherapy for localized pancreatic ductal adenocarcinoma.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 369-369
Author(s):  
Pat Gulhati ◽  
Laura Prakash ◽  
Matthew H. G. Katz ◽  
Xuemei Wang ◽  
Milind M. Javle ◽  
...  
Keyword(s):  
Pancreatic Ductal Adenocarcinoma ◽  
Metastatic Disease ◽  
Locally Advanced ◽  
Standard Of Care ◽  
Clinical Staging ◽  
Ductal Adenocarcinoma ◽  
First Line ◽  
First Line Therapy ◽  
Kaplan Meier ◽  
Ecog Ps

369 Background: Chemotherapy is widely used as a component of treatment of localized pancreatic ductal adenocarcinoma (PDAC). Pre-operative chemotherapy is associated with early treatment of micro-metastases and guaranteed delivery of all components of multimodality therapy. For locally advanced (LA) PDAC, induction chemotherapy is standard of care. We evaluated the use of gemcitabine and nab-paclitaxel (Gem/nab-P) as first-line therapy in localized PDAC. Methods: Records of pts with localized PDAC who initiated Gem/nab-P at a single institution from 2013-2015 were retrospectively reviewed. Clinicopathologic features, dose and outcomes were evaluated. Pts were staged using our previously published criteria: potentially resectable (PR), borderline type A (BR-A) (anatomy amenable to vascular resection), BR-B (biology suspicious for metastatic disease including high CA19-9), BR-C (co-morbidities requiring medical optimization), and LA. Co-morbidities were classified using adult comorbidity evaluation-27 score. Overall survival (OS) was analyzed using Kaplan Meier method. Results:99 pts [M/F: 50/49; median age: 70 yrs (range 30-85); PR/BR/LA: 45/14/40] were treated with Gem/nab-P. Clinical staging showed PR+BR-A/BR-B+C: 20/39. BR-B+C included one or more of the following factors: age ≥80 yrs [13%], ECOG PS ≥2 [13%], moderate/severe co-morbidities [55%], CA19-9≥1000 [28%], suspicion for metastatic disease [21%]. Majority of pts received biweekly Gem/nab-P dosing [standard/biweekly/other: 10/80/9] with minimal grade 4 toxicity. 45/99 pts received chemoradiation after Gem/nab-P [30Gy/50.4Gy: 15/30]. 12/20 (60%) PR+BR-A, 2/39 (5%) BR-B+C and 1/40 (3%) LA pts underwent pancreatectomy. 13/15 resected pts received adjuvant chemotherapy. At median follow-up of 26 mo, median OS was 18 (95% CI: 15.6-20.5) mo for all, 17 (95% CI: 14.6-19.5) mo for unresected and not reached for resected pts (p = 0.03). Conclusions: A significant number of pts with resectable PDAC albeit aggressive biology (BR-B) and/or medically inoperable disease (BR-C) received first-line Gem/nab-P; resection rates were lower compared to PR/BR-A pts. Biweekly dosing is being used in localized PDAC and is well tolerated.

191 Association of immune related adverse events with the efficacy of immune checkpoint inhibitors in metastatic renal cell carcinoma

2020 ◽  
Vol 8 (Suppl 3) ◽  
pp. A205-A206
Author(s):  
Vasilii Bushunow ◽  
Leonard Appleman ◽  
Roby Thomas
Keyword(s):  
Renal Cell Carcinoma ◽  
Adverse Events ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Checkpoint Inhibitors ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy ◽  
Kaplan Meier

BackgroundImmune checkpoint inhibitors (ICI) are first-line therapy for tumors including metastatic renal cell carcinoma (mRCC). Use of ICI is complicated by diverse immune-related adverse events (irAEs), which can add significant morbidity but are also associated with improved efficacy of therapy.1 2 Risk factors for development of irAE are still poorly understood. We hypothesized that patients with mRCC treated with ICI as first-line therapy have higher rates of developing irAE’s than patients previously treated with other therapies.MethodsWe conducted a single-institution, retrospective medical record review of patients with mRCC treated with immune-checkpoint inhibitors from March 2011 through April 15, 2020. We identified therapy duration, and presence, severity, and treatment of adverse events. We defined overall survival as time elapsed from date of diagnosis until death or until completion of study. We classified severity of adverse events according to CTCAE guidelines. Statistical methods included univariate Cox proportional hazards and logistic regression models, and Kaplan-Meier curves were plotted for subgroups.ResultsA total of 64 unique charts were reviewed. 18 patients (28%) of patients were treated with ICI as first-line therapy. 28 patients (44%) experienced immune-related adverse events with a total of 40 irAE’s identified. Most irAE were grade I-II (78%), with 7 (17%) grade III and 1 (2.4%) grade IV irAE’s. Most common sites were skin (29%), thyroid (20%) and gastrointestinal (15%). Patients with irAE had increased survival compared to those who did not have irAE (median survival not reached, vs 139 weeks, p=0.0004) (figure 1). This finding remained after excluding patients who had only experienced dermatologic irAE (median survival not reached in non-derm irAE subgroup, vs 144 weeks for dermatologic or no irAE, p=0.01) (figure 2). Patients treated with ICI as first line therapy had greater rates of developing irAE (72%) than those who had prior therapies (32%) (OR 5.4; p = 0.006). There was no association between histology type and rate of irAE.Abstract 191 Figure 1Kaplan-Meier survival plot of OS between patients with any irAE and those without any irAEAbstract 191 Figure 2Kaplan-Meier survival plot of OS between patients with non-dermatologic irAE and those without any irAE or only dermatologic irAEConclusionsThe development of irAE’s in patients with mRCC treated with ICI is associated with longer survival. This study joins the growing body of evidence showing that presence of irAE’s is associated with increased treatment efficacy. Use of ICI as first-line therapy is associated with higher risk of irAE. Given growing use of ICI as first-line therapy, further study to predict onset and severity of irAE’s is required.AcknowledgementsHong Wang, PhD, for statistical support.Ethics ApprovalThis study was approved by the University of Pittsburgh Institutional Review Board. Approval number STUDY19100386.ReferencesElias R, Yan N, Singla N, Levonyack N, Formella J, Christie A, et al. Immune-related adverse events are associated with improved outcomes in ICI-treated renal cell carcinoma patients. J Clin Oncol 2019;37(7):S645.Verzoni E, Cartenì G, Cortesi E, et al. Real-world efficacy and safety of nivolumab in previously-treated metastatic renal cell carcinoma, and association between immune-related adverse events and survival: the Italian expanded access program. J Immunother Cancer 2019;7(1):99.

Ifosfamide- and cisplatin-containing chemotherapy as first-line salvage therapy in germ cell tumors: response and survival.

1997 ◽  
Vol 15 (7) ◽  
pp. 2559-2563 ◽  
Author(s):  
J A McCaffrey ◽  
M Mazumdar ◽  
D F Bajorin ◽  
G J Bosl ◽  
V Vlamis ◽  
...  
Keyword(s):  
Germ Cell ◽  
Median Survival ◽  
Primary Tumor ◽  
Median Survival Time ◽  
Germ Cell Tumors ◽  
Tumor Site ◽  
First Line ◽  
Primary Tumor Site ◽  
First Line Therapy ◽  
Line Therapy

PURPOSE To evaluate the efficacy and toxicity of ifosfamide- and cisplatin-containing chemotherapy as first-line salvage treatment for patients with germ cell tumors (GCT). PATIENTS AND METHODS Fifty-six patients with advanced GCT resistant to one prior cisplatin-containing regimen were treated with a salvage chemotherapy regimen of ifosfamide, cisplatin, and either vinblastine or etoposide (VeIP/VIP). RESULTS Twenty of 56 (36%) assessable patients achieved a complete response (CR). Thirteen (23%) are alive and continuously free of disease at a median follow-up time of 52 months; the median survival duration was 18 months. Among patients with a testis primary tumor site and a prior CR to first-line therapy, 65% are alive and 41% continuously disease-free, and the median survival time has not been reached. In contrast, for patients with an extragonadal primary tumor or with a testis primary tumor site and an incomplete response (IR) to first-line therapy, 31% are alive and 15% continuously free of disease, with a median survival time of 12 months (P < .03). CONCLUSION Ifosfamide- and cisplatin-containing therapy achieves a durable CR in a minority of patients with resistant GCT as first-line therapy. Patients with a primary testis site who relapsed from a CR to first-line cisplatin therapy have a better prognosis than patients with an extragonadal primary tumor site or an IR to first-line therapy. Risk-directed clinical trials to improve response and survival in both subsets are warranted.

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