scholarly journals Time to Definitive Failure to the First Tyrosine Kinase Inhibitor in Localized GI Stromal Tumors Treated With Imatinib As an Adjuvant: A European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group Intergroup Randomized Trial in Collaboration With the Australasian Gastro-Intestinal Trials Group, UNICANCER, French Sarcoma Group, Italian Sarcoma Group, and Spanish Group for Research on Sarcomas

2015 ◽  
Vol 33 (36) ◽  
pp. 4276-4283 ◽  
Author(s):  
Paolo G. Casali ◽  
Axel Le Cesne ◽  
Andres Poveda Velasco ◽  
Dusan Kotasek ◽  
Piotr Rutkowski ◽  
...  
Keyword(s):  
Overall Survival ◽  
High Risk ◽  
Randomized Trial ◽  
Data Monitoring Committee ◽  
Adjuvant Imatinib ◽  
Secondary Resistance ◽  
Free Survival ◽  
End Point ◽  
Significant Difference ◽  
Advanced Gist

Purpose In 2004, we started an intergroup randomized trial of adjuvant imatinib versus no further therapy after R0-R1 surgery patients with localized, high- or intermediate-risk GI stromal tumor (GIST). Patients and Methods Patients were randomly assigned to 2 years of imatinib 400 mg daily or no further therapy after surgery. The primary end point was overall survival; relapse-free survival (RFS), relapse-free interval, and toxicity were secondary end points. In 2009, given the concurrent improvement in prognosis of patients with advanced GIST, we changed the primary end point to imatinib failure–free survival (IFFS), with agreement of the independent data monitoring committee. We report on a planned interim analysis. Results A total of 908 patients were randomly assigned between December 2004 and October 2008: 454 to imatinib and 454 to observation. Of these, 835 patients were eligible. With a median follow-up of 4.7 years, 5-year IFFS was 87% in the imatinib arm versus 84% in the control arm (hazard ratio, 0.79; 98.5% CI, 0.50 to 1.25; P = .21); RFS was 84% versus 66% at 3 years and 69% versus 63% at 5 years (log-rank P < .001); and 5-year overall survival was 100% versus 99%, respectively. Among 528 patients with high-risk GIST by local pathologist, 5-year IFFS was 79% versus 73%; among 336 centrally reviewed high-risk patients, it was 77% versus 73%, respectively. Conclusion This study confirms that adjuvant imatinib has an overt impact on RFS. No significant difference in IFFS was observed, although in the high-risk subgroup there was a trend in favor of the adjuvant arm. IFFS was conceived as a potential end point in the adjuvant setting because it is sensitive to secondary resistance, which is the main adverse prognostic factor in patients with advanced GIST.

scholarly journals Metastasis-Free Survival Is a Strong Surrogate of Overall Survival in Localized Prostate Cancer

2017 ◽  
Vol 35 (27) ◽  
pp. 3097-3104 ◽  
Author(s):  
Wanling Xie ◽  
Meredith M. Regan ◽  
Marc Buyse ◽  
Susan Halabi ◽  
Philip W. Kantoff ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
High Risk ◽  
Treatment Effects ◽  
Significant Risk ◽  
Localized Prostate Cancer ◽  
Free Survival ◽  
Risk Of Death ◽  
End Point ◽  
Kendall’S Τ

Purpose Adjuvant therapy for intermediate-risk and high-risk localized prostate cancer decreases the number of deaths from this disease. Surrogates for overall survival (OS) could expedite the evaluation of new adjuvant therapies. Methods By June 2013, 102 completed or ongoing randomized trials were identified and individual patient data were collected from 28 trials with 28,905 patients. Disease-free survival (DFS) and metastasis-free survival (MFS) were determined for 21,140 patients from 24 trials and 12,712 patients from 19 trials, respectively. We evaluated the surrogacy of DFS and MFS for OS by using a two-stage meta-analytic validation model by determining the correlation of an intermediate clinical end point with OS and the correlation of treatment effects on both the intermediate clinical end point and OS. Results Trials enrolled patients from 1987 to 2011. After a median follow-up of 10 years, 45% of 21,140 men and 45% of 12,712 men experienced a DFS and MFS event, respectively. For DFS and MFS, 61% and 90% of the patients, respectively, were from radiation trials, and 63% and 66%, respectively, had high-risk disease. At the patient level, Kendall’s τ correlation with OS was 0.85 and 0.91 for DFS and MFS, respectively. At the trial level, R2 was 0.86 (95% CI, 0.78 to 0.90) and 0.83 (95% CI, 0.71 to 0.88) from weighted linear regression of 8-year OS rates versus 5-year DFS and MFS rates, respectively. Treatment effects—measured by log hazard ratios—for the surrogates and OS were well correlated ( R2, 0.73 [95% CI, 0.53 to 0.82] for DFS and 0.92 [95% CI, 0.81 to 0.95] for MFS). Conclusion MFS is a strong surrogate for OS for localized prostate cancer that is associated with a significant risk of death from prostate cancer.

Imatinib failure-free survival (IFS) in patients with localized gastrointestinal stromal tumors (GIST) treated with adjuvant imatinib (IM): The EORTC/AGITG/FSG/GEIS/ISG randomized controlled phase III trial.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 10500-10500 ◽  
Author(s):  
Paolo Giovanni Casali ◽  
Axel Le Cesne ◽  
Andres Poveda Velasco ◽  
Dusan Kotasek ◽  
Piotr Rutkowski ◽  
...  
Keyword(s):  
High Risk ◽  
Kinase Inhibitor ◽  
Phase Iii ◽  
Open Label ◽  
Eligibility Criteria ◽  
Secondary Resistance ◽  
Significance Level ◽  
End Point ◽  
Consensus Classification ◽  
Advanced Gist

10500 Background: In 2004 we launched an open-label randomized trial with adjuvant IM for 2 yrs in localized, surgically resected, high/intermediate-risk GIST. Methods: Pts were randomized between 2 yrs of IM, 400 mg daily, and no further therapy after surgery. The primary end-point was OS, while RFS, RFI and toxicity were secondary end-points. Main eligibility criteria were: age >18 yrs, PS 0-2, localized CD117-positive GIST, intermediate or high risk according to the 2002 Consensus classification, R0 or R1 surgical margins, no previous medical therapy. Pts were stratified by risk, tumor site and margins. An accrual of 400 pts was planned, then escalated to 900. Given the prognostic improvement of advanced GIST pts, in 2009 the study IDMC authorized to change the primary end-point into IFS, whose failure was defined as the time when a different tyrosine kinase inhibitor (TKI) is started. We report on a planned interim analysis carried out after 115 events according to the new primary end-point, with a significance level of 1.5%. Hazard ratios (HR) and p-values were adjusted for stratification factors. Results: 908 pts were randomized between 2005 and 2008, 454 to IM and 454 to observation arm; 835 pts were eligible. 17% of pts treated with IM stopped early due to toxicity or refusal. With a median follow-up of 4.7 yrs, 5-yr IFS was 87% in the IM-arm vs 84% in the control arm (HR=0.80, 98.5% CI [0.51; 1.26], p=0.23); RFS was 84% vs 66% at 3 yrs, and 69% vs 63% at 5 yrs (p<0.001); 5-yr OS was 100% vs 99%. Among 528 pts with high-risk GIST by local pathology, 5-yr IFS was 79% vs 73% (p=0.11), and 77% vs 73% (p=0.44) amongst 336 high-risk GIST pts by centrally reviewed pathology. Conclusions: This study confirms that adjuvant IM has an overt impact on short-term freedom from relapse. In the high-risk subgroup, a non-statistically significant trend in favor of the adjuvant arm was observed in terms of IFS. This new end-point for the adjuvant setting, i.e. survival free from any failure of the first employed TKI, was designed to incorporate secondary resistance, i.e. the currently main factor adversely affecting prognosis of advanced GIST pts. Clinical trial information: NCT00103168.

Retrospective Comparison Of Survival and Leukemic Transformation In Myelofibrosis Patients Treated With Ruxolitinib Versus Momelotinib Versus Fedratinib Versus Pomalidomide

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 4049-4049
Author(s):  
Animesh Pardanani ◽  
Ramy A. Abdelrahman ◽  
Kebede Begna ◽  
Darci Zblewski ◽  
Aref Al-Kali ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Overall Survival ◽  
High Risk ◽  
Standard Therapy ◽  
Leukemic Transformation ◽  
Free Survival ◽  
Retrospective Comparison ◽  
Significant Difference ◽  
Long Term Follow Up

Abstract Background The impact of JAK inhibitor (JAKi) therapy on the natural history of myelofibrosis remains unclear. While a Phase 3 study showed that overall survival of ruxolitinib-treated intermediate-2 or high-risk myelofibrosis patients was superior as compared to placebo-treated patients, it remains unclear whether such an advantage would persist in patients receiving standard therapy, and whether this result is generalizable to other JAK inhibitors. We conducted a sponsor-independent, single-center retrospective analysis of overall and leukemia-free survival after long-term follow up in patients receiving JAKi treatment with comparison to two control populations: (i) a contemporaneously diagnosed (2005 onwards) primary myelofibrosis (PMF) patient cohort receiving standard therapy (JAKi and pomalidomide naïve); and (ii) a pomalidomide treated patient cohort (JAKi-naïve). Methods Baseline clinical, cytogenetic and molecular data were collected at the onset of study treatment with the first JAKi or pomalidomide, or at the time of first referral for patients receiving standard therapy. Information regarding bone marrow karyotype and DIPSS-plus risk status was available for all patients. Information on survival and leukemic transformation was updated in July 2013. Results The 3 patient groups were: (i) JAKi-treated: n=157, median age 65 years, range 34-89. DIPSS-plus risk: Low/Int-1 20 (13%), Int-2 66 (42%), and High 71 (45%). Median follow up from first JAKi treatment was 30 months (range 1-67 months); during this period, 72 deaths (46%) and 14 (9%) leukemic transformations were documented. The first JAKi was ruxolitinib in 51 patients (33%), momelotinib (CYT387) in 79 (50%), and fedratinib (SAR302503) in 27 (17%). The proportion of patient deaths and leukemic transformation (median follow up, range) per specific JAKi was: ruxolitinib 57% and 12% (40 months, 2-67), momelotinib 43% and 9% (29 months, 1-42), and fedratinib 33% and 4% (21 months, 2-53), respectively. (ii) Control#1 (Pomalidomide-treated): n=69, median age 67 years, range 36-87. DIPSS-plus risk: Low/Int-1 0 (0%), Int-2 28 (41%), and High 41 (59%). Median follow up was 25 months (range 2-70 months); during this period, 47 deaths (68%) and 7 (10%) leukemic transformations were documented. (iii) Control# 2 (Standard therapy): n=319, median age 66 years, range 22-90. DIPSS-plus risk: Low/Int-1 98 (31%), Int-2 122 (38%), and High 99 (31%). Median follow up from time of referral was 18 months (range 1-92 months); during this period, 101 deaths (32%) and 18 (6%) leukemic transformations were documented. For patients with Int-2 or high-risk disease (n=221), 92 deaths (42%) and 13 (6%) leukemic transformations were recorded (median follow up 16 months, range 1-92). The survival analysis focused on DIPSS-plus Int-2 and high-risk patients for all groups, reflecting the population predominantly selected for treatment on JAKi clinical trials. There was no significant difference in the median overall survival of myelofibrosis patients treated with JAKi (39 months) versus standard therapy (35 months) versus pomalidomide (26 months) (p=0.12) (Figure). The 5-year survival rates were 31%, 33% and 26%, respectively. Similarly, the median overall survival of patients treated with ruxolitinib (35 months), momelotinib (37 months) or fedratinib (42 months) was not significantly different (p=0.4). Baseline DIPSS-plus status (ie, Int-2 vs. high-risk) effectively stratified JAKi treated patients in terms of overall survival (median survival 31 vs. 60 months; p=0.0002). There was no significant difference in leukemia-free survival when comparing JAKi-treated patients versus standard therapy verus pomalidomide-treated patients (p=0.6) (Figure). The estimated 5-year risk of leukemic transformation was 17%, 12% and 13%, respectively. Conclusions With long-term follow up, myelofibrosis patients receiving JAKi therapy exhibited similar overall and leukemia-free survival as compared to two control populations (DIPSS-plus matched standard therapy and pomalidomide-treated patients). Baseline DIPSS-plus status was a powerful predictor of overall survival in JAKi treated patients. While underscoring the limitation of a non-head-to-head retrospective comparison, there was no significant difference in overall or leukemia-free survival when comparing individual JAKi drugs. Disclosures: Pardanani: Bristol Myers Squibb: Clinical trial support Other; Sanofi: Clinical trial support, Publication support services, Clinical trial support, Publication support services Other; PharmaMar: Clinical trial support, Clinical trial support Other; JW Pharmaceutical Corp.: Clinical trial support, Clinical trial support Other. Off Label Use: Use of Ruxolitinib, Momelotinib, Fedratinib and Pomalidomide for treatment of Myelofibrosis in Clinical Trial setting.

Outcome of Epithelial Ovarian Cancer: Time for Strategy Trials to Resolve the Problem of Optimal Timing of Surgery

2015 ◽  
Vol 25 (6) ◽  
pp. 993-999 ◽  
Author(s):  
Gregg Van de Putte ◽  
Jolien Oben ◽  
Leen Prenen ◽  
Jean Christophe Schobbens ◽  
Jos Vlasselaer ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Overall Survival ◽  
Randomized Trial ◽  
Disease Free Survival ◽  
Debulking Surgery ◽  
Free Survival ◽  
Large Databases ◽  
Significant Difference ◽  
Advanced Stages ◽  
Disease Free

IntroductionThe standard treatment of ovarian cancer is the combination of debulking surgery and chemotherapy. There is an ongoing discussion on which treatment is best: primary debulking surgery (PDS) or neoadjuvant chemotherapy with interval debulking (NACT-IDS). Even a large randomized trial has not settled this issue. We examined whether comparing a specified treatment protocol would not be a more logical approach to answer this type of discussions.MethodsA retrospective study of 142 consecutively treated patients according to a fixed protocol between 2000 and 2012 was conducted. Disease-free survival and overall survival were calculated by univariate and multivariate analyses for the whole group and for advanced stages separately. Specific differences between PDS and NACT-IDS were studied. Comparison of results from large databases was made.ResultsDisease-free survival and overall 5-year survival for the whole group were 35% and 50%. For the advanced stages, disease-free survival and overall 5-year survival were 14% and 36%, with a median disease-free and overall survival of 16 and 44 months. Of the 98 women with advanced ovarian carcinoma, 54% of operable patients underwent PDS and 44% underwent NACT-IDS. More patients in the PDS group were optimally (<1 cm) debulked: 80% vs 71%. There was no significant difference in survival between PDS or NACT-IDS. Optimally debulked patients had a significant better overall survival in multivariate analysis with a hazard ratio of 2.1.DiscussionOutcome of treatment according to a fixed protocol with a mixture of PDS and NACT-IDS was similar to results from large databases. We hypothesize that comparison of a specific strategy may yield more useful results than awaiting the perfect randomized trial.

scholarly journals RTID-05. INDIGO: A GLOBAL, RANDOMIZED, DOUBLE-BLIND, PHASE 3 STUDY OF VORASIDENIB (AG-881) VS PLACEBO IN PATIENTS WITH RESIDUAL/RECURRENT GRADE II GLIOMA WITH AN ISOCITRATE DEHYDROGENASE 1/2 (IDH1/2) MUTATION

2020 ◽  
Vol 22 (Supplement_2) ◽  
pp. ii194-ii194
Author(s):  
Ingo Mellinghoff ◽  
Martin van den Bent ◽  
Jennifer Clarke ◽  
Elizabeth Maher ◽  
Katherine Peters ◽  
...  
Keyword(s):  
High Risk ◽  
Dose Escalation ◽  
Objective Response ◽  
Data Monitoring Committee ◽  
Progression Free Survival ◽  
High Risk Population ◽  
Low Grade ◽  
Who Grade ◽  
Free Survival ◽  
Grade Ii

Abstract BACKGROUND Low-grade gliomas (LGGs; WHO grade II) are incurable and ultimately progress to high-grade gliomas. The current treatment options are surgery followed by observation (“watch and wait”) for patients with lower risk for disease progression or postoperative chemoradiotherapy (high-risk population). There are no approved targeted therapies. IDH1 and IDH2 mutations (mIDH1/2) occur in approximately 80% and 4% of LGGs, respectively, and promote tumorigenesis via neomorphic production of D-2-hydroxyglutarate. Vorasidenib, an oral, potent, reversible, brain-penetrant pan-inhibitor of mIDH1/2, was evaluated in 76 patients with glioma in two phase 1 studies (dose escalation and perioperative) and was associated with a favorable safety profile at daily doses below 100 mg. Preliminary clinical activity was observed in non-enhancing glioma patients in both studies, with an objective response rate (ORR) of 18.2% and median progression-free survival of 31.4 months in the dose escalation study. METHODS Approximately 366 patients will be randomized 1:1 to vorasidenib (50 mg QD) or matched placebo and stratified by 1p19q status (intact vs co-deleted). Key eligibility criteria: age ≥ 12 years; grade II oligodendroglioma or astrocytoma (per WHO 2016 criteria) not in need of immediate treatment and without high-risk features; centrally confirmed mIDH1/2 status; ≥ 1 surgery for glioma with most recent ≥ 1 year but ≤ 5 years before randomization, and no other anticancer therapy; Karnofsky performance status ≥ 80%; and centrally confirmed measurable, non-enhancing disease evaluable by magnetic resonance imaging. Crossover from placebo to the vorasidenib arm is permitted upon centrally confirmed radiographic progression per RANO-LGG criteria. Primary endpoint: progression-free survival assessed by independent review. Secondary endpoints: safety and tolerability, tumor growth rate assessed by volume, ORR, overall survival, and quality of life. Clinical data will be reviewed regularly by an independent data monitoring committee. The study is currently enrolling patients in the US, with additional countries planned (NCT04164901).

scholarly journals Evaluation of efficacy and toxicity of nivolumab combined with or without docetaxel in patients with advanced NSCLC

2021 ◽  
Author(s):  
Yang Wang ◽  
Jun Nie ◽  
Ling Dai ◽  
Weiheng Hu ◽  
Jie Zhang ◽  
...  
Keyword(s):  
Overall Survival ◽  
Advanced Nsclc ◽  
Objective Response ◽  
Progression Free Survival ◽  
Meaningful Improvement ◽  
Free Survival ◽  
Significant Difference ◽  
Grade 3 ◽  
Doublet Chemotherapy ◽  
Platinum Doublet

Abstract Background The combination of PD-1/PD-L1 inhibitor and chemotherapy has been clinically confirmed to be beneficial as the first-line treatment of patients with advanced NSCLC. This study aimed to assess the effect of nivolumab + docetaxel versus nivolumab monotherapy in patients with NSCLC after the failure of platinum doublet chemotherapy. Materials and methods The efficacy and toxicity of nivolumab + docetaxel combination therapy versus nivolumab monotherapy were compared in this retrospective study. Primary endpoint of the study was progression-free survival (PFS), and the secondary endpoints were objective response rate (ORR), overall survival (OS), and toxicity. Results Between November 2017 and December 2019, 77 patients were included in this study, with 58 patients in the nivolumab group and 19 in the nivolumab + docetaxel group. The median follow-up was 18 months, and the PFS was 8 months for patients receiving nivolumab + docetaxel and 2 months for those receiving nivolumab alone (p = 0.001), respectively. Nivolumab + docetaxel showed superior OS compared with nivolumab, with the median OS unreached versus 7 months (p = 0.011). Among patients without EGFR/ALK variation, compared to nivolumab monotherapy, nivolumab + docetaxel showed better PFS (p = 0.04) and OS (p  = 0.05). There was no significant difference in grade 3–4 adverse events (AEs) between the two groups (p = 0.253). Conclusions The combination of nivolumab and docetaxel demonstrated a meaningful improvement in progression-free survival and overall survival compared to nivolumab monotherapy, in patients with NSCLC after the failure of platinum doublet chemotherapy, irrespective of EGFR/ALK variation status.

Randomized Trial of Adjuvant Chemotherapy With Mitomycin, Fluorouracil, and Cytosine Arabinoside Followed by Oral Fluorouracil in Serosa-Negative Gastric Cancer: Japan Clinical Oncology Group 9206–1

2003 ◽  
Vol 21 (12) ◽  
pp. 2282-2287 ◽  
Author(s):  
Atsushi Nashimoto ◽  
Toshifusa Nakajima ◽  
Hiroshi Furukawa ◽  
Masatsugu Kitamura ◽  
Taira Kinoshita ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Overall Survival ◽  
Adjuvant Chemotherapy ◽  
Survival Benefit ◽  
Curative Resection ◽  
Cancer Recurrence ◽  
Phase Iii ◽  
Relapse Free Survival ◽  
Free Survival ◽  
Significant Difference

Purpose: To evaluate the survival benefit of adjuvant chemotherapy after curative resection in serosa-negative gastric cancer patients (excluding patients who were T1N0), we conducted a multicenter phase III clinical trial in which 13 cancer centers in Japan participated. Patients and Methods: From January 1993 to December 1994, 252 patients were enrolled into the study and allocated randomly to adjuvant chemotherapy or surgery alone. The chemotherapy comprised intravenous mitomycin 1.33 mg/m2, fluorouracil (FU) 166.7 mg/m2, and cytarabine 13.3 mg/m2 twice weekly for the first 3 weeks after surgery, and oral FU 134 mg/m2 daily for the next 18 months for a total dose of 67 g/m2. The primary end point was relapse-free survival. Overall survival and the site of recurrence were secondary end points. Results: Ninety-eight percent of patients underwent gastrectomy with D2 or greater lymph node dissection. There were no treatment-related deaths and few serious adverse events. There was no significant difference in relapse-free and overall survival between the arms (5-year relapse-free survival 88.8% chemotherapy v 83.7% surgery alone; P = .14 and 5-year survival 91.2% chemotherapy v 86.1% surgery alone; P = .13, respectively). Nine patients (7.1%) in the chemotherapy arm and 17 patients (13.8%) in the surgery-alone arm had cancer recurrence. Conclusion: There was no statistically significant relapse-free or overall survival benefit with this adjuvant chemotherapy for patients with macroscopically serosa-negative gastric cancer after curative resection, and there was no statistical difference between the two arms relating to the types of cancer recurrence. We do not recommend adjuvant chemotherapy with this regimen for this population in clinical practice.

Radiofrequency Ablation With or Without Transcatheter Arterial Chemoembolization in the Treatment of Hepatocellular Carcinoma: A Prospective Randomized Trial

2013 ◽  
Vol 31 (4) ◽  
pp. 426-432 ◽  
Author(s):  
Zhen-Wei Peng ◽  
Yao-Jun Zhang ◽  
Min-Shan Chen ◽  
Li Xu ◽  
Hui-Hong Liang ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Overall Survival ◽  
Prognostic Factors ◽  
Transcatheter Arterial Chemoembolization ◽  
Recurrence Free Survival ◽  
Treatment Allocation ◽  
Free Survival ◽  
End Point ◽  
Tumor Number ◽  
Arterial Chemoembolization

Purpose To compare radiofrequency ablation (RFA) with or without transcatheter arterial chemoembolization (TACE) in the treatment of hepatocellular carcinoma (HCC). Patients and Methods A randomized controlled trial was conducted on 189 patients with HCC less than 7 cm at a single tertiary referral center between October 2006 and June 2009. Patients were randomly asssigned to receive TACE combined with RFA (TACE-RFA; n = 94) or RFA alone (n = 95). The primary end point was overall survival. The secondary end point was recurrence-free survival, and the tertiary end point was adverse effects. Results At a follow-up of 7 to 62 months, 34 patients in the TACE-RFA group and 48 patients in the RFA group had died. Thirty-three patients and 52 patients had developed recurrence in the TACE-RFA group and RFA group, respectively. The 1-, 3-, and 4-year overall survivals for the TACE-RFA group and the RFA group were 92.6%, 66.6%, and 61.8% and 85.3%, 59%, and 45.0%, respectively. The corresponding recurrence-free survivals were 79.4%, 60.6%, and 54.8% and 66.7%, 44.2%, and 38.9%, respectively. Patients in the TACE-RFA group had better overall survival and recurrence-free survival than patients in the RFA group (hazard ratio, 0.525; 95% CI, 0.335 to 0.822; P = .002; hazard ratio, 0.575; 95% CI, 0.374 to 0.897; P = .009, respectively). There were no treatment-related deaths. On logistic regression analyses, treatment allocation, tumor size, and tumor number were significant prognostic factors for overall survival, whereas treatment allocation and tumor number were significant prognostic factors for recurrence-free survival. Conclusion TACE-RFA was superior to RFA alone in improving survival for patients with HCC less than 7 cm.

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