Second-Line Chemotherapy With Irinotecan Plus Carmustine in Glioblastoma Recurrent or Progressive After First-Line Temozolomide Chemotherapy: A Phase II Study of the Gruppo Italiano Cooperativo di Neuro-Oncologia (GICNO)

2004 ◽  
Vol 22 (23) ◽  
pp. 4779-4786 ◽  
Author(s):  
Alba A. Brandes ◽  
Alicia Tosoni ◽  
Umberto Basso ◽  
Michele Reni ◽  
Francesco Valduga ◽  
...  
Keyword(s):  
Phase Ii ◽  
Karnofsky Performance Status ◽  
Therapeutic Option ◽  
Performance Status ◽  
Progression Free Survival ◽  
Second Line ◽  
First Line ◽  
Free Survival ◽  
Irinotecan Dose ◽  
Line Chemotherapy

Purpose Glioblastoma multiforme (GBM), the most frequent brain tumor in adults, is not considered chemosensitive. Nevertheless, there is widespread use of first-line chemotherapy, often with temozolomide, as a therapeutic option in patients with progressive disease after surgery and radiotherapy. However, at the time of second recurrence and/or progression, active and noncross-resistant chemotherapy regimens are required. The aim of the present multicenter phase II trial, therefore, was to ascertain the efficacy of second-line carmustine (BCNU) and irinotecan chemotherapy. Patients and Methods Patients with histologically confirmed GBM, recurring or progressing after surgery, standard radiotherapy and a first-line temozolomide-based chemotherapy, were considered eligible. The primary end-point was progression-free survival at 6 months (PFS-6), and secondary end-points included response rate, toxicity, and survival. All patients were on enzyme-inducing antiepileptic prophylaxis. Chemotherapy consisted of BCNU (100 mg/m2 on day 1) plus irinotecan (175 mg/m2/weekly for 4 weeks), every 6 weeks, for a maximum of eight cycles. In the absence of grade 2 toxicity, the irinotecan dose was increased to 200 mg/m2. Results A total of 42 patients (median age, 53.4 years; median Karnofsky performance status, 80; range, 60 to 90) were included in the study. PFS-6 was 30.3% (95% CI, 18.5% to 49.7%). Median time to progression was 17 weeks (95% CI, 11.9 to 23.9). Nine partial responses (21.4%; 95% CI, 9% to 34%) were obtained. Toxicity was manageable. Conclusion The BCNU plus irinotecan regimen seems active and non–cross-resistant in patients with GBM with recurrence after temozolomide-based chemotherapy.

Phase 3 clinical Trial Evaluating 90y glass microspheres in patients with metastatic colorectal carcinoma of the liver who have failed first-line chemotherapy.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 474-474
Author(s):  
Maria Angela Karpf
Keyword(s):  
Clinical Trial ◽  
Performance Status ◽  
Randomized Study ◽  
Progression Free Survival ◽  
Second Line ◽  
Glass Microspheres ◽  
First Line ◽  
Phase 3 ◽  
Free Survival ◽  
Line Chemotherapy

474 Background: Colorectal cancer (CRC) is the third most common cancer in the US. Half of pts diagnosed with CRC develop liver disease. Unresectable liver metastases are responsible for morbidity/mortality. Typically, pts with metastatic CRC receive an oxaliplatin- or irinotecan-based regimen as first-line chemotherapy, +/- bevacizumab. On progression, pts are treated with the regimen they did not receive during first-line chemo. A study to evaluate yttrium 90 glass microspheres (TheraSphere; 90Y) in pts with unresectable mCRC of the liver showed that pts with good performance status, no extrahepatic metastases, and ≤ 25% tumor may benefit most from 90Y. 90Y glass microspheres are approved by FDA under a Humanitarian Device Exemption (HDE). This study will evaluate outcomes in this patient subset when 90Y is added to second-line SOC chemo. The objective is to evaluate efficacy/safety of 90Y in patients with liver mCRC that has progressed after first-line chemo. Methods: Open-label, multi-center, randomized study to evaluate 90Y treatment in ~340 eligible pts, in whom SOC 2nd-line chemo with either an oxaliplatin or irinotecan-based regimen is planned. Eligible pts will be randomized 1:1 to control or treatment. Treatment pts will receive a first cycle of second-line chemo within 21 days of randomization and at least 14 days after the last dose of first-line agents including VEGF inhibitors. 90Y will be administered in place of the second chemotherapy cycle. Control pts will receive planned SOC second-line chemo. Primary endpoint is progression-free survival. Secondary: overall survival, hepatic progression-free survival, time to symptomatic progression, tumor response rate, and adverse events. Pts will have regular study visits as long as they participate, at which time safety/efficacy data will be collected and recorded. Results: NA Conclusions: Given the potential benefit to mCRC pts, this Phase 3 study will evaluate 90Y in the second-line setting in patients who have progressed following SOC first-line chemotherapy. Clinical trial information: NCT01483027.

Oral vinorelbine as a second-line chemotherapy option in advanced malignant pleural mesothelioma.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e20073-e20073
Author(s):  
Raul Rogelio Trejo Rosales ◽  
Jose Gustavo Nuñez Cerrillo ◽  
Juan Carlos Silva Godinez ◽  
Rodrigo Fernando Riera Sala ◽  
Maritza Peña Campos
Keyword(s):  
Performance Status ◽  
Progression Free Survival ◽  
Pleural Mesothelioma ◽  
Second Line ◽  
First Line ◽  
Second Line Therapy ◽  
Oral Vinorelbine ◽  
Free Survival ◽  
Line Therapy ◽  
Line Chemotherapy

e20073 Background: Malignant pleural mesothelioma (MPM) is an infrequent entity with a poor prognosis. Standard first line chemotherapy therapy is based on pemetrexed and cisplatin, however, there is no established standard second-line therapy. We report our experience with patients treated at a third-level referral center in Mexico, making emphasis in the use of oral vinorelbine. Methods: We conducted a retrospective cohort study of MPM patients treated between 2012 and 2018 at the Centro Médico Nacional Siglo XXI, a third-level referral center in Mexico City. Our objective was to evaluate the effectiveness of different second-line chemotherapy schemes in MPM patients. Results: A total of 143 patients were included. There were 47 women (32.8%) and 96 men (67.1%). Median age was 64 (range 39 - 86). The histological subtypes comprised of 73.4 % epitheloid, 9 % with a sarcomatoid component and 17.4% not otherwise specified. The majority of patients presented with advanced disease 32.1 stage III and 63.6 stage IV. 72% of patients had performance status 0-1, however 9.7% of patients had performance status 3-4 at diagnosis, and received only palliative care as treatment. A total of 125 patients received first-line chemotherapy, and 40 patients underwent second-line therapy. Usual schemes were based on pemetrexed, paclitaxel, gemcitabine and oral vinolrebine. Overall, partial response rate was 5% and stable disease was 35%. There were no statistical differences in response rates between schemes (p = 0.75). The most usual second-line scheme was oral vinolrebine. Progression-free survival was 4 months in vinolrebine-treated patients vs 2 months (HR 1.04, 95% CI 0.86 – 1.25, p = 0.63) as compared with patients treated with other schemes. Conclusions: Our results are comparable with similar series in the second-line scenario. Oral-vinolrebine treatment progression-free survival was similar to other, more toxic drugs. However, we included few patients. More work is needed to identify the characteristics of benefitting patients.

Preliminary results from a phase II study of infusional 5-FU, leucovorin, and irinotecan (FOLFIRI) plus bevacizumab as first-line treatment for metastatic colorectal cancer (mCRC)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 3579-3579 ◽  
Author(s):  
S. Kopetz ◽  
J. L. Abbruzzese ◽  
C. Eng ◽  
R. B. Adinin ◽  
J. Morris ◽  
...  
Keyword(s):  
Phase Ii ◽  
Performance Status ◽  
Progression Free Survival ◽  
Line Treatment ◽  
First Line ◽  
Curative Surgery ◽  
Free Survival ◽  
Preliminary Results ◽  
Grade 3 ◽  
First Line Treatment

3579 Background: Irinotecan (I) plus bolus 5-FU (F) and leucovorin (L) comprise the IFL regimen, a very active treatment in mCRC when combined with bevacizumab (B). The response rate (RR) for IFL-B given as first-line treatment is 45%, with a median progression-free survival (PFS) of 10.6 months and a median survival of 20.3 months. The IFL regimen is now considered inferior to infusional 5-FU regimens, such as FOLFIRI, which have less toxicity and improved efficacy. Methods: We designed a 43 patient (pt), single-arm phase II trial of FOLFIRI-B with B (5mg/kg), I (180mg/m2), bolus of F (400mg/m2) and L (400mg/m2) followed by a 46-hour infusion of F (2400mg/m2), with a primary endpoint of progression-free survival (PFS). Chemotherapy naïve mCRC patients (pts) with adequate organ function and performance status 0–2 received B alone on Day minus 14, starting FOLFIRI + B on Day 1. DCE-MRI and laboratory correlates were completed before and after B alone and cycle 1. Once cycle is equivalent to two weeks. Results: 21 pts, median age 59 y/o (range 26–75), M:F = 15:6, 4 with prior F in adjuvant setting, have been enrolled to date. 20 pts are evaluable for response. One pt is too early. A total of 215 cycles have been administered (median 11). Median PFS has not been reached after a median follow-up of 8 months. By intent-to-treat analysis, there were 14 PRs (70%), and 5 (25%) pts with stable disease observed (including 1 unconfirmed PR). PRs were observed from 9 to 35 weeks after the first cycle (median: 18 weeks). 9 pts remain on treatment (1–12 months); 12 pts are off study (3 for progressive disease, 1 withdrew, 4 sent for curative surgery, 2 for toxicity, 2 sent for surgery unrelated to cancer). Toxicity included 10 cases of grade 3 neutropenia, including 1 febrile neutropenia, 4 venous thrombi, and 6 cases of hypertension requiring medication change. One pt included in the analysis developed peritonitis, considered a possible microperforation, after B alone and never received FOLFIRI. No ≥ grade 3 diarrhea was observed. Analysis of correlative studies will be presented at a later date. Conclusion: Our preliminary results indicate that FOLFIRI-B is well tolerated and an excellent choice as a first-line treatment for mCRC. [Table: see text]

Phase II trial of irinotecan, S-1, and bevacizumab (IRIS/Bev) combination chemotherapy as second line for advanced colorectal cancer (NCCSG04).

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 496-496
Author(s):  
Yasumasa Takii ◽  
Kouichi Hurukawa ◽  
Satoshi Maruyama ◽  
Toshiyuki Yamazaki ◽  
Jun Nishimura ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Phase Ii ◽  
Primary Endpoint ◽  
Phase Ii Trial ◽  
Progression Free Survival ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Free Survival ◽  
Line Therapy

496 Background: The FIRIS study (Muro K et al. Lancet Oncol 2010;11:853-860) previously demonstrated the non-inferiority of Irinotecan plus S-1 (IRIS) to FOLFIRI for metastatic colorectal cancer (mCRC), with progression-free survival as the primary endpoint. IRIS plus bevacizumab (IRIS/Bev) was reported an active and generally well-tolerated first-line treatment for mCRC (Yuki et al. ASCO 2012 #3593). We planned a Phase II trial to evaluate the efficacy and safety of IRIS/Bev as second-line therapy for patients with mCRC. Methods: The study design was multicenter, single-arm, open-label phase II study. Eligible patients had to have mCRC with confirmed diagnosis of adenocarcinoma, history of oxaliplatin containing regimen as first-line therapy, an age from 20 to 80 years, ECOG performance status (PS) of 0-1. S-1 65 mg/m2 daily p.o. was given on days 1-14 and Irinotecan 75mg/m2 and Bevacizumab 10mg/kg i.v. were given on days 1 and 15 of a 28-day cycle. The primary endpoint was progression-free survival (PFS). The secondary endpoints included overall response rate (OR), overall survival (OS), time to treatment failure (TTF) and safety. Results: From 08/12 until 11/06, 35 patients were enrolled. One patient did not start therapy. Thirty-four patients were investigated. Median age was 63 years (range, 38 to 82). Twenty-five patients were male. The mean of relative dose intensity of TS-1/Irinotecan/Bev were respectively 92.1%/87.0%/86.2%. The OR was 21.1% (7/33) and disease control rate was 84.8% (28/33). Median PFS was 9.3 months, median TTF was 8.2 month and median survival time 23.1 month. On safety analysis, the incidence of grade 3 or 4 adverse reactions were as follows: neutropenia, 14.7%; fatigue, 14.7%; white blood cell decreased, 11.8%; anorexia, 8.8%; anemia, 8.8%; diarrhea, 2.9%; proteinuria, 5.9%; thromboembolic event, 2.9%. Conclusions: IRIS/Bev is an active and well-tollarated second-line treatment for patients with mCRC. Clinical trial information: UMIN000001631.

Impact of first-line cisplatin versus non-cisplatin based chemotherapy on progression-free survival in patients with advanced urothelial carcinoma previously treated with perioperative cisplatin based chemotherapy.

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 335-335
Author(s):  
Jennifer A Locke ◽  
Gregory Russell Pond ◽  
Guru Sonpavde ◽  
Andrea Necchi ◽  
Patrizia Giannatempo ◽  
...  
Keyword(s):  
Urothelial Carcinoma ◽  
Progression Free Survival ◽  
Cox Proportional Hazards ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Free Survival ◽  
Ecog Ps ◽  
Line Chemotherapy ◽  
First Line Treatment

335 Background: Perioperative cisplatin based chemotherapy (PCBC) is a standard of care in the management of muscle invasive urothelial carcinoma (UC). Cisplatin based (C) therapy also represents the historical first line treatment of metastatic disease. There is however no data to guide the optimal choice of first line chemotherapy regimen – C re-treatment vs other second-line or non cisplatin regimens (NC) –in UC patients who relapse after receiving PCBC. This multicenter retrospective study compares C vs NC first line treatment on progression-free survival (PFS) for patients (pts) with advanced UC after PCBC and cystectomy. Methods: Data were collected for patients who received various first-line chemotherapies for advanced UC following previous PCBC therapy. Cox proportional hazards models were used to investigate the prognostic ability of type of peri-operative / first-line chemotherapy, visceral metastasis, ECOG status, time from prior chemotherapy (TFPC), anemia, leukocytosis and albumin on PFS. Results: Data were available for 145 pts from 12 centers. The mean age was 62 years, 113 (77.9%) were men and ECOG-PS was 0 or >0 in 74 (51.0%) and 61 (42.0%) patients. Ninety-one (62.8%) pts received C first line, the median number of cycles was 4 (range 1-17) and the median TFPC was 6.2 months (range 1-154). Median overall survival was 86 weeks (95% CI 70-106) and median PFS was 24 (95% CI 18-27) weeks. Time from perioperative chemotherapy (TFPC) (>52 weeks vs ≤52 weeks; HR 0.63 p=0.027) and ECOG-PS at first line (1+ vs 0; HR 1.73 p=0.010), were prognostic of PFS. No significant effect was noted for C vs NC first line (p=0.70); however, among patients with TFPC >52 weeks, patients with NC had worse PFS (median 4.6 months, 95% CI 1.8-12.2) than those who received C (median 8.1, 95% CI 3.2-16.3). Conclusions: There is no evidence to suggest overall superiority of C vs NC based first line chemotherapy or a second-line regimen in patients with advanced UC who received prior PCBC. However, those with TFPC >52 weeks should probably receive C first line chemotherapy given better PFS with C.

Progression-free survival as an endpoint for clinical trials in first-line metastatic urothelial cancer.

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 251-251
Author(s):  
Matt D. Galsky ◽  
Susanne Krege ◽  
Chia-Chin Lin ◽  
Noah M. Hahn ◽  
Thorsten Ecke ◽  
...  
Keyword(s):  
Phase Ii ◽  
Urothelial Cancer ◽  
Performance Status ◽  
Progression Free Survival ◽  
Line Treatment ◽  
Phase Ii Trials ◽  
First Line ◽  
Free Survival ◽  
Metastatic Urothelial Cancer ◽  
First Line Treatment

251 Background: Advances in the first-line treatment of metastatic urothelial cancer (UC) have proven elusive. The lack of appropriate intermediate endpoints to screen the activity of novel regimens may be a barrier to progress, particularly in this disease state characterized by relatively high response rates but short response durations. Progression-free-survival (PFS) at fixed time points may overcome several of the limitations of response rate-based endpoints, but would be further supported by establishing benchmarks and demonstrating a correlation between PFS and overall survival (OS). Methods: Data were pooled from eight phase II and III trials evaluating first-line cisplatin-based chemotherapy in metastatic UC. Landmark analyses for progression at 3, 6, and 9 months after treatment initiation were performed to minimize lead-time bias. A proportional hazards model was used to assess the utility of PFS for predicting OS. Results: 545 patients were included in the analysis. The median PFS was 7.75 months (95% CI, 7.06, 8.18) and the median OS was 12.35 months (95% CI, 10.97, 13.44). The results of the landmark analysis, adjusted for performance status ≥ 1 and presence of visceral metastases, is shown in the Table. By using the Fleischer model, the estimated correlation between PFS and OS was 0.86 (bootstrap standard error 0.001, 95% CI 0.83, 0.89). Conclusions: PFS at 3, 6, and 9 months predicted OS in this analysis of patients with metastatic UC treated with first-line cisplatin-based chemotherapy. This analysis provides benchmarks, and support, for the use of PFS as an endpoint for phase II trials screening the activity of novel regimens as first-line treatment for metastatic UC. [Table: see text]

scholarly journals Bevacizumab in First-Line Chemotherapy Improves Progression-Free Survival for Advanced Ovarian Clear Cell Carcinoma

Cancers ◽  
2021 ◽  
Vol 13 (13) ◽  
pp. 3177
Author(s):  
Shinichi Tate ◽  
Kyoko Nishikimi ◽  
Ayumu Matsuoka ◽  
Satoyo Otsuka ◽  
Yuki Shiko ◽  
...  
Keyword(s):  
Cell Carcinoma ◽  
Clear Cell ◽  
Clear Cell Carcinoma ◽  
Performance Status ◽  
Progression Free Survival ◽  
Patient Characteristics ◽  
Wilcoxon Test ◽  
First Line ◽  
Free Survival ◽  
Line Chemotherapy

(1) Background: We investigated survival outcomes following first-line chemotherapy before and after approval of bevacizumab (Bev) for ovarian cancer in Japan to evaluate the efficacy of Bev for advanced clear cell carcinoma (CCC). (2) Methods: We investigated 28 consecutive patients diagnosed with CCC (stages III/IV) at our hospital between 2008 and 2018. Bev was administered for treatment of advanced CCC after approval in Japan in November 2013. Progression-free survival (PFS) was compared between 10 patients treated before Bev approval (2008–2013, Bev- group) and 18 patients treated after Bev approval (2014–2018, Bev+ group) for first-line chemotherapy. (3) Results: No intergroup difference was observed in patient characteristics. The rate of completeness of resection was higher in the Bev − group (9/10, 90%) than in the Bev+ group (15/18, 83%) (p = 0.044). Eleven (61%) patients in the Bev + group received ≥ 21 cycles of Bev. The median PFS increased from 12.0 months before Bev approval to 29.8 months after Bev approval (Wilcoxon test, p = 0.026). Multivariate analysis showed that performance status (p = 0.049), Bev administration (p = 0.023) and completeness of resection (p = 0.023) were independent prognostic factors for PFS. (4) Conclusions: Bev incorporated into first-line chemotherapy might improve PFS in patients with advanced CCC. We hope that our findings will be confirmed in adequate clinical trials.

scholarly journals Efficacy of second-line treatment and prognostic factors in patients with advanced malignant peritoneal mesothelioma: a retrospective study

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Rui Kitadai ◽  
Tatsunori Shimoi ◽  
Kazuki Sudo ◽  
Emi Noguchi ◽  
Yusuke Nagata ◽  
...  
Keyword(s):  
Overall Survival ◽  
Median Overall Survival ◽  
Progression Free Survival ◽  
Peritoneal Mesothelioma ◽  
Second Line ◽  
Malignant Peritoneal Mesothelioma ◽  
First Line ◽  
Free Survival ◽  
Second Line Chemotherapy ◽  
Line Chemotherapy

Abstract Background Standard treatment for malignant peritoneal mesothelioma has not been established, and systemic chemotherapy is administered according to malignant pleural mesothelioma. We previously reported the efficacy of cisplatin plus pemetrexed as first-line chemotherapy; however, the efficacy of second-line chemotherapy remains unknown. Methods We retrospectively evaluated patients with malignant peritoneal mesothelioma who started first-line systemic chemotherapy with platinum plus pemetrexed between March 2007 and February 2019 at the National Cancer Center Hospital. Patients who received second-line chemotherapy after failure of platinum plus pemetrexed were identified. We evaluated the efficacy of first- and second-line chemotherapy, and explored the prognostic factors. Survival outcomes were estimated using the Kaplan–Meier method, and between-group differences were compared using the log-rank test. Univariate and multivariate analyses were performed using Cox proportional hazards models. Results A total of 54 and 26 patients received platinum plus pemetrexed as first- and second-line chemotherapy, respectively (gemcitabine in 12 patients; taxane, six; nivolumab, three; and others, five). In all patients, the median overall survival and progression-free survival after first-line chemotherapy were 16.6 and 7.3 months, respectively. Among patients who received second-line chemotherapy, the median overall survival, progression-free survival, and second-line overall survival were 16.9, 3.2, and 9.9 months, respectively. Patients who received ≥6 cycles of platinum plus pemetrexed as first-line chemotherapy had longer overall survival after second-line chemotherapy than those who did not (hazard ratio, 0.23; 95% confidence interval: 0.06–0.82; p = 0.02). Conclusions Second-line chemotherapy may be an option for refractory malignant peritoneal mesothelioma, especially in patients who have completed 6 cycles of platinum plus pemetrexed as first-line chemotherapy.

scholarly journals TheraSphere Yttrium-90 Glass Microspheres Combined With Chemotherapy Versus Chemotherapy Alone in Second-Line Treatment of Patients With Metastatic Colorectal Carcinoma of the Liver: Protocol for the EPOCH Phase 3 Randomized Clinical Trial (Preprint)

2018 ◽  
Author(s):  
Nikhil Chauhan ◽  
Mary F Mulcahy ◽  
Riad Salem ◽  
Al B Benson III ◽  
Eveline Boucher ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Disease Progression ◽  
Progression Free Survival ◽  
Control Group ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Phase 3 ◽  
Free Survival ◽  
Line Chemotherapy

BACKGROUND Colorectal cancer is one of the most common cancers and causes of cancer-related death. Up to approximately 70% of patients with metastatic colorectal cancer (mCRC) have metastases to the liver at initial diagnosis. Second-line systemic treatment in mCRC can prolong survival after development of disease progression during or after first-line treatment and in those who are intolerant to first-line treatment. OBJECTIVE The objective of this study is to evaluate the efficacy and safety of transarterial radioembolization (TARE) with TheraSphere yttrium-90 (90Y) glass microspheres combined with second-line therapy in patients with mCRC of the liver who had disease progression during or after first-line chemotherapy. METHODS EPOCH is an open-label, prospective, multicenter, randomized, phase 3 trial being conducted at up to 100 sites in the United States, Canada, Europe, and Asia. Eligible patients have mCRC of the liver and disease progression after first-line chemotherapy with either an oxaliplatin-based or irinotecan-based regimen and are eligible for second-line chemotherapy with the alternate regimen. Patients were randomized 1:1 to the TARE group (chemotherapy with TARE in place of the second chemotherapy infusion and subsequent resumption of chemotherapy) or the control group (chemotherapy alone). The addition of targeted agents is permitted. The primary end points are progression-free survival and hepatic progression-free survival. The study objective will be considered achieved if at least one primary end point is statistically significant. Secondary end points are overall survival, time to symptomatic progression defined as Eastern Cooperative Oncology Group Performance Status score of 2 or higher, objective response rate, disease control rate, quality-of-life assessment by the Functional Assessment of Cancer Therapy-Colorectal Cancer questionnaire, and adverse events. The study is an adaptive trial, comprising a group sequential design with 2 interim analyses with a planned maximum of 420 patients. The study is designed to detect a 2.5-month increase in median progression-free survival, from 6 months in the control group to 8.5 months in the TARE group (hazard ratio [HR] 0.71), and a 3.5-month increase in median hepatic progression-free survival time, from 6.5 months in the control group to 10 months in the TARE group (HR 0.65). On the basis of simulations, the power to detect the target difference in either progression-free survival or hepatic progression-free survival is >90%, and the power to detect the target difference in each end point alone is >80%. RESULTS Patient enrollment ended in October 2018. The first interim analysis in June 2018 resulted in continuation of the study without any changes. CONCLUSIONS The EPOCH study may contribute toward the establishment of the role of combination therapy with TARE and oxaliplatin- or irinotecan-based chemotherapy in the second-line treatment of mCRC of the liver. CLINICALTRIAL ClinicalTrials.gov NCT01483027; https://clinicaltrials.gov/ct2/show/NCT01483027 (Archived by WebCite at http://www.webcitation.org/734A6PAYW) INTERNATIONAL REGISTERED REPOR RR1-10.2196/11545

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