Long-term survival outcome of E1201: An Eastern Cooperative Oncology Group (ECOG) randomized phase II trial of neoadjuvant preoperative paclitaxel/cisplatin/radiotherapy (RT) or irinotecan/cisplatin/RT in endoscopy with ultrasound (EUS) staged esophageal adenocarcinoma.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 69-69 ◽  
Author(s):  
Lawrence Kleinberg ◽  
Paul J. Catalano ◽  
Arlene A. Forastiere ◽  
Steven M. Keller ◽  
Pramila R. Anne ◽  
...  
Keyword(s):  
Esophageal Adenocarcinoma ◽  
Phase Ii ◽  
Performance Status ◽  
Pathologic Complete Response ◽  
Eastern Cooperative Oncology Group ◽  
Phase Ii Trials ◽  
Term Survival ◽  
Long Term Survival ◽  
C 30

69 Background: E1201 included operable esophageal adenocarcinoma, staged II-IVa by EUS and accrual ended Oct 2004. The primary endpoint was pathologic complete response (pCR), a surrogate endpoint generally associated with survival which did not meet criteria for further study of either arm. Long term survival results are now available. Stratification included clinical/EUS stage and ECOG performance status (PS). Methods: 81 eligible patients (pts) began treatment. Arm A was cisplatin (C) 30mg/m2 and irinotecan (I) 50 mg/m2 on days (d) 1, 8, 22, 29 of 45 Gy RT/5 weeks. Post-op therapy was C 30 mg/m2 and I 65 mg/m2 d 1, 8 q21 days x 3. Arm B therapy was C 30 mg/m2 and paclitaxel (P) 50 mg/m2 1 hour infusion d 1, 8, 15, 22, 29 with RT. Postoperative therapy was C 75 mg/m2 and P 175 mg/m2 day 1 q21 days x 3. Results: In Arm A, 26/39 have died. Median survival (S) is 35 m (months) and the 5, 6, and 7 year S was 46%, 39%, and 35%. In Arm B, 31/42 pts have died (one pt refused follow-up). Median S in arm B is 21 m. The 5, 6, and 7 year S was 27%, 27%, and 23%. Survival by EUS stage strata: For strata 1 (Stages T2N0M0 or T3N0M0), 14/20 have died. Median S is 37 m and 5 year S is 44%. In stage stratum 2 (Stages T1-3N1M0 or T1-3N0-1M1a), 43/61 have died. Median S is 24 m and 5 year S is 34%. For PS Strata: Patients with PS 0, had median S 35 m and 5 year S of 37% whereas for those with PS 1, the outcomes were 20m and 35%. Survival differences for the treatments and for these strata were not statistically significant. Conclusions: Long term survival is similar for both treatment arms and does not appear superior to results achieved with 5FU based regimens. The prognostic importance of the pretreatment strata was not confirmed. These data, along with the reported pCR (15% arm A; 17% arm B) and toxicity data (> =grade 3 during chemo/RT 68% arm A; 65% arm B), may have importance in aiding in the design and interpretation of ongoing and planned phase II trials adding novel agents or treatment approaches to backbones built on variations of these two regimens.

Long-term survival in phase II trials of gemcitabine plus cisplatin for advanced transitional cell cancer

2002 ◽  
Vol 7 (4) ◽  
pp. 153-157 ◽  
Author(s):  
Walter M Stadler ◽  
Annamaria Hayden ◽  
Hans von der Maase ◽  
Debasish Roychowdhury ◽  
Luigi Dogliotti ◽  
...  
Keyword(s):  
Phase Ii ◽  
Cell Cancer ◽  
Transitional Cell ◽  
Phase Ii Trials ◽  
Term Survival ◽  
Long Term Survival ◽  
Transitional Cell Cancer

Long-term survival of patients with metastatic renal cell carcinoma (mRCC) treated with targeted therapy (TT) without cytoreductive nephrectomy (CN).

2011 ◽  
Vol 29 (7_suppl) ◽  
pp. 346-346
Author(s):  
S. L. Richey ◽  
S. H. Culp ◽  
E. Jonasch ◽  
P. G. Corn ◽  
L. C. Pagliaro ◽  
...  
Keyword(s):  
Primary Tumor ◽  
Group Performance ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Outcome Data ◽  
Term Survival ◽  
Long Term Survival ◽  
Kaplan Meier ◽  
Targeted Agent

346 Background: We recently reported on 188 patients (pts) with mRCC treated with TT without CN [Richey et al, J Clin Oncol 28:15s, 2010 (suppl; abstr 4613); Annals of Oncology- in press]. We report here outcome data on pts who survived > 24 months (mos). Methods: We retrospectively reviewed records of patients with mRCC who received TT without CN and survived longer than 24 mos from treatment initiation. Pts did not undergo CN due to medical comorbidity, unresectable primary tumor, heavy disease burden, or patient preference. Kaplan-Meier methods were used to estimate median overall survival (OS). Long-term complications related to therapy were evaluated. Results: 22 pts were identified meeting the inclusion criteria. Median follow-up was 30.4 mos (range, 24.1- 68.7), with median OS time of 34.1 mos (95% CI: 30.2, 37.2). Median time on therapy (TOT) was 25.3 mos (IQR: 13.7, 28.5). Six pts (27.3%) were alive at the time of analysis, with median TOT of 26.9 mos (range: 13.7, 62.5) (IQR: 24.6, 33.4). Eastern Cooperative Oncology Group performance status was 0 or 1 in 86% of pts. Ten (45%) and 12 (55%) pts had intermediate- and poor-risk disease by Heng et al criteria (JCO 2009), respectively. Patients received the following types of TT: sunitinib 14 (63.6%), sorafenib 13 (59.1%), temsirolimus 5 (22.7%), bevacizumab 5 (22.7%), pazopanib 3 (13.6%), everolimus 4 (18.2%), erlotinib 3 (13.6%), investigational targeted agent 1 (4.6%). Four (18.2%), 5 (22.7%), and 13 (59.1%) pts received 1, 2, or ≥ 3 different therapies, respectively. During treatment with TT, 6 pts (27.3%) developed hypertension, 6 pts (27.3%) developed hypothyroidism, 2 pts (9.1%) developed congestive heart failure, 1 pt (4.6%) developed stroke. No pts developed bleeding or myocardial infarction. By radiographic assessment of best primary tumor response, 4 (18.2%) pts had a partial response (≥30% decrease), 10 (45.5%) exhibited a decrease <30%, and 6 (27.3%) had stable or increased size of the primary tumor. Conclusions: These data highlight the potential for long-term survival of patients with mRCC treated with TT without CN, and underscore the challenges in managing therapy-related long-term adverse events. No significant financial relationships to disclose.

Long-term survival in patients with metastatic melanoma who received ipilimumab in four phase II trials.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 9053-9053 ◽  
Author(s):  
Celeste Lebbé ◽  
Jeffrey S. Weber ◽  
Michele Maio ◽  
Bart Neyns ◽  
Kaan Harmankaya ◽  
...  
Keyword(s):  
Metastatic Melanoma ◽  
Disease Progression ◽  
Phase Ii ◽  
Survival Data ◽  
Phase Iii ◽  
Phase Ii Trials ◽  
Term Survival ◽  
Long Term Survival

9053 Background: Ipilimumab (Ipi) has shown improved overall survival (OS) in two phase III trials of patients (pts) with metastatic melanoma (MM), with survival follow-up of >4 years in one trial. The present analyses provide survival follow-up of >5 years in four phase II trials of Ipi in MM. Methods: Pts with MM were enrolled in one of four phase II trials: (1) CA184-004, a biomarker study with Ipi at 3 or 10 mg/kg in treatment-naive (TN) and previously treated (PT) pts; (2) CA184-007, with Ipi at 10 mg/kg +/- prophylactic budesonide in TN and PT pts; (3) CA184-008, a single-arm study with Ipi at 10 mg/kg in PT pts; and (4) CA184-022, a dose-ranging study of Ipi at 0.3, 3, or 10 mg/kg in PT pts (crossover from lower dose groups to 10 mg/kg was allowed upon disease progression). Ipi was administered q3 wk x4 (induction), followed by maintenance (q12 wk from week 24) in eligible pts. Some pts were retreated with Ipi at 10 mg/kg upon disease progression. Along with survival data collected through March 2012 for studies 007, 008, and 022, we report updated 5-year OS data for study 004 collected through September 2012. Results: Five-year OS rates for TN and PT pts are reported in studies 007, 008, and 022, with combined analyses for TN and PT pts within each dose group in study 004 (Table). The results show that survival rates reach a plateau beginning at year 3. Conclusions: In pts who received Ipi at 3 or 10 mg/kg in phase II studies, regardless of prior treatment, a proportion (12.3–49.5%) remained alive 5 years after the start of treatment. These results demonstrate long-term survival with Ipi therapy in MM. An ongoing phase III trial will compare OS for Ipi at 3 vs 10 mg/kg in pts with MM. Clinical trial information: NCT00162123. [Table: see text]

Defects in DNA repair genes and long-term survival in cisplatin-based neoadjuvant chemotherapy for muscle invasive bladder cancer (MIBC).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 4536-4536
Author(s):  
Benjamin Miron ◽  
Eric A. Ross ◽  
Fern Anari ◽  
John O'Neill ◽  
Jean H. Hoffman-Censits ◽  
...  
Keyword(s):  
Neoadjuvant Chemotherapy ◽  
Phase Ii ◽  
Pathologic Complete Response ◽  
Predictive Biomarkers ◽  
Complete Response ◽  
Phase Ii Trials ◽  
Two Phase ◽  
Term Survival

4536 Background: Although cisplatin-based neoadjuvant chemotherapy (NAC) has demonstrated an overall survival (OS) benefit in MIBC, only a subset of patients have pathologic complete response (pT0) at cystectomy. ATM, RB1 and FANCC mutations have shown correlation with pT0 to cisplatin-based NAC, as previously published. We now report updated OS and disease specific survival (DSS) from two phase II trials using these gene alterations as biomarkers. Methods: Patients with stage T2-T4 (N0 or N1) MIBC were enrolled in phase II trials of dose-dense NAC with MVAC (methotrexate, vinblastine, adriamycin, and cisplatin; NCT01031420) or GC (gemcitabine and cisplatin; NCT01611662). Patients were treated with NAC with plan for curative cystectomy. DNA from pretreatment tumor tissue was sequenced for coding exons of 287 cancer-related genes and analyzed for mutations. Survival in patients with one or more mutations in ATM, RB1, or FANCC genes was compared to those without mutations. Results: Of 58 pts treated, 38% (22/58 pts) had relevant mutations in the combined group of MVAC (13/34 pts) and GC (9/24 pts) trials. At a median follow-up of 56 months and minimum follow up of 16 months, patients with mutations had statistically significantly greater OS (p = 0.0043) and DSS (p = 0.0015). Median OS/DSS was not reached for patients with a mutation in any group. At 5 years post treatment, OS/DSS were greater in mutated vs non-mutated patients in all groups (see table). Conclusions: Long-term follow up reveals that previously reported improved responses to cisplatin-based NAC associated with mutations in ATM, RB1 and FANCC also confer a clinically meaningful and statistically significant survival benefit in these patients. These alterations may be useful as predictive biomarkers to allow clinicians to prioritize patients most likely to benefit from NAC prior to radical cystectomy. [Table: see text]

scholarly journals Immunohistochemical evaluation for P53 and VEGF (Vascular Endothelial Growth Factor) is not prognostic for long term survival in end stage esophageal adenocarcinoma

2009 ◽  
Vol 36 (1) ◽  
pp. 24-34 ◽  
Author(s):  
Leandro Totti Cavazzola ◽  
André Ricardo Pereira da Rosa ◽  
Carlos Cauduro Schirmer ◽  
Richard Ricachenevski Gurski ◽  
João Pedro Bueno Telles ◽  
...  
Keyword(s):  
Esophageal Adenocarcinoma ◽  
Curative Resection ◽  
P53 Protein ◽  
Vascular Endothelial ◽  
Clinicopathological Factors ◽  
Term Survival ◽  
Long Term Survival ◽  
End Stage ◽  
Endothelial Growth Factor

OBJECTIVES: To correlate the expression of p53 protein and VEGF with the prognosis of patients submitted to curative resection to treat esophageal adenocarcinoma. METHODS: Forty-six patients with esophageal adenocarcinoma, submitted to curative resection, were studied. The expressions of p53 protein and VEGF were assessed by immunohistochemistry in 52.2% and 47.8% of tumors, respectively. RESULTS: P53 protein and VEGF expressions coincided in 26% of the cases, and no correlation between these expressions was observed. None of the clinicopathological factors showed a significant correlation with p53 protein or VEGF expressions. There was no significant association between p53 protein and VEGF expressions and long-term survival. CONCLUSION: The expression of p53 protein and VEGF did not correlate with prognosis in esophageal adenocarcinoma patients submitted to curative resection.

scholarly journals Long -Term Survival in Stage IV Esophageal Adenocarcinoma with Chemoradiation and Serial Endoscopic Cryoablation

2017 ◽  
Vol 50 (5) ◽  
pp. 491-494 ◽  
Author(s):  
Zachary Spiritos ◽  
Parit Mekaroonkamol ◽  
Bassel F. El Rayes ◽  
Seth D. Force ◽  
Steven A. Keilin ◽  
...  
Keyword(s):  
Esophageal Adenocarcinoma ◽  
Stage Iv ◽  
Term Survival ◽  
Long Term Survival

M1592 Long-Term Survival Following Endoscopic and Surgical Treatment of Mucosal (T1a) Esophageal Adenocarcinoma in Barrett's Esophagus

2008 ◽  
Vol 134 (4) ◽  
pp. A-378
Author(s):  
Ganapathy A. Prasad ◽  
Rami J. Badreddine ◽  
Navtej Buttar ◽  
Louis-Michel Wong Kee Song ◽  
Dennis A. Wigle ◽  
...  
Keyword(s):  
Surgical Treatment ◽  
Barrett’S Esophagus ◽  
Esophageal Adenocarcinoma ◽  
Barrett's Esophagus ◽  
Term Survival ◽  
Long Term Survival
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