Three-year overall survival update from the PACIFIC trial.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 8526-8526 ◽  
Author(s):  
Jhanelle Elaine Gray ◽  
Augusto E. Villegas ◽  
Davey B. Daniel ◽  
David Vicente ◽  
Shuji Murakami ◽  
...  
Keyword(s):  
Overall Survival ◽  
Survival Rates ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
Smoking History ◽  
Rank Test ◽  
Kaplan Meier ◽  
Primary Endpoints ◽  
The Pacific ◽  
Patient Reported

8526 Background: In the phase 3 PACIFIC study of patients with unresectable, Stage III NSCLC without progression after chemoradiotherapy (CRT), durvalumab demonstrated significant improvements versus placebo in the primary endpoints of progression-free survival (HR, 0.52; 95% CI, 0.42–65; P < 0.0001) and overall survival (OS; HR, 0.68; 95% CI, 0.53–0.87; P = 0.00251). Safety was similar and durvalumab had no detrimental effect on patient-reported outcomes. Here, we report 3-year OS rates for all patients randomized in the PACIFIC study. Methods: Patients with WHO PS 0/1 (any tumor PD-L1 status) who received ≥2 cycles of platinum-based CRT were randomized (2:1), 1–42 days following CRT, to receive durvalumab 10 mg/kg intravenously every 2 weeks or placebo, up to 12 months, and stratified by age, sex, and smoking history. OS was analyzed using a stratified log-rank test in the ITT population. Medians and OS rates at 12, 24 and 36 months were estimated by Kaplan-Meier method. Results: In total, 713 patients were randomized of whom 709 received treatment (durvalumab, n = 473; placebo, n = 236). The last patient had completed the protocol-defined 12 months of study treatment in May 2017. As of January 31, 2019 (data cutoff), 48.2% of patients had died (44.1% and 56.5% in the durvalumab and placebo groups, respectively). The median duration of follow-up was 33.3 months (range, 0.2–51.3). Updated OS remained consistent with that previously reported (stratified HR 0.69, 95% CI, 0.55–0.86), with the median not reached (NR; 95% CI, 38.4 months–NR) with durvalumab versus 29.1 months (95% CI, 22.1–35.1) with placebo. The 12-, 24- and 36-month OS rates with durvalumab and placebo were 83.1% versus 74.6%, 66.3% versus 55.3%, and 57.0% versus 43.5%, respectively. After discontinuation, 43.3% and 57.8% in the durvalumab and placebo groups, respectively, received subsequent anticancer therapy (9.7% and 26.6% subsequently received immunotherapy). OS subgroup results will be presented. Conclusions: Updated OS data from PACIFIC, including 3-year survival rates, underscore the long-term clinical benefit with durvalumab following CRT and further establish the PACIFIC regimen as the standard of care in this population. Clinical trial information: NCT02125461.

Five-year survival outcomes with durvalumab after chemoradiotherapy in unresectable stage III NSCLC: An update from the PACIFIC trial.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 8511-8511
Author(s):  
David R. Spigel ◽  
Corinne Faivre-Finn ◽  
Jhanelle Elaine Gray ◽  
David Vicente ◽  
David Planchard ◽  
...  
Keyword(s):  
Progression Free Survival ◽  
Standard Of Care ◽  
Phase Iii ◽  
Stage Iii ◽  
Smoking History ◽  
Kaplan Meier ◽  
Unresectable Stage ◽  
The Pacific ◽  
Patient Reported ◽  
Stage Iii Nsclc

8511 Background: In the placebo-controlled Phase III PACIFIC trial of patients with unresectable Stage III NSCLC whose disease had not progressed after platinum-based concurrent chemoradiotherapy (cCRT), durvalumab improved overall survival (OS) (stratified hazard ratio [HR] 0.68; 95% confidence interval [CI] 0.53–0.87; p=0.0025; data cutoff [DCO] Mar 22, 2018) and progression-free survival (PFS) (stratified HR 0.52, 95% CI 0.42–0.65; p<0.0001; DCO Feb 13, 2017) based on the DCOs used for the primary analyses, and the degree of benefit remained consistent in subsequent updates. Durvalumab was associated with a manageable safety profile, and did not detrimentally affect patient-reported outcomes, compared with placebo. These findings established consolidation durvalumab after CRT (the ‘PACIFIC regimen’) as the standard of care in this setting. We report updated, exploratory analyses of OS and PFS, assessed approximately 5 years after the last patient was randomized. Methods: Patients with WHO PS 0/1 (and any tumor PD-L1 status) whose disease did not progress after cCRT (≥2 overlapping cycles) were randomized (2:1) 1–42 days following cCRT (total prescription radiotherapy dose typically 60–66 Gy in 30–33 fractions) to receive 12 months’ durvalumab (10 mg/kg IV every 2 weeks) or placebo, stratified by age (<65 vs ≥65 years), sex, and smoking history (current/former smoker vs never smoked). The primary endpoints were OS and PFS (blinded independent central review; RECIST v1.1) in the intent-to-treat (ITT) population. HRs and 95% CIs were estimated using stratified log-rank tests in the ITT population. Medians and OS/PFS rates at 60 months were estimated with the Kaplan–Meier method. Results: Overall, 709/713 randomized patients received treatment in either the durvalumab (n/N=473/476) or placebo (n/N=236/237) arms. The last patient had completed study treatment in May 2017. As of Jan 11, 2021 (median follow-up duration of 34.2 months in all patients; range, 0.2–74.7 months), updated OS (stratified HR 0.72, 95% CI 0.59–0.89; median 47.5 vs 29.1 months) and PFS (stratified HR 0.55, 95% CI 0.45–0.68; median 16.9 vs 5.6 months) remained consistent with the results from the primary analyses. The 60-month OS rates were 42.9% and 33.4% with durvalumab and placebo, respectively, and 60-month PFS rates were 33.1% and 19.0%, respectively. Updated treatment effect estimates for patient subgroups will be presented. Conclusions: These updated survival analyses, based on 5-year data from PACIFIC, demonstrate robust and sustained OS plus durable PFS benefit with the PACIFIC regimen. An estimated 42.9% of patients randomized to durvalumab remain alive at 5 years and approximately a third remain both alive and free of disease progression. Clinical trial information: NCT02125461.

scholarly journals Mortality and Survival Rates after Elective Hepatic Surgery in a Low-Volume Centre Are Comparable to Those of High-Volume Centres

ISRN Surgery ◽  
2012 ◽  
Vol 2012 ◽  
pp. 1-5 ◽  
Author(s):  
I. E. Nygård ◽  
K. Lassen ◽  
J. Kjæve ◽  
A. Revhaug
Keyword(s):  
Overall Survival ◽  
Liver Resection ◽  
Survival Rates ◽  
Disease Free Survival ◽  
High Volume ◽  
Colorectal Metastases ◽  
Rank Test ◽  
Cox Proportional Hazard ◽  
Kaplan Meier ◽  
Low Volume

Background. Over the last decades, liver resection has become a frequently performed procedure in western countries because of its acceptance as the most effective treatment for patients with selected cases of metastatic tumours. The purpose of this study was to evaluate the results after hepatic resections performed electively in our centre since 1979 and compare the results to those of larger high-volume centres. Methods. Medical records of all patients who underwent liver resection from January 1979 to December 2011 were reviewed. Disease-free survival and overall survival were determined by Kaplan-Meier analysis. Risk factors for complications were tested with the log-rank test and the Cox proportional hazard model. Complications were classified according to the modified Clavien classification system. Results. 290 elective liver resections were performed between January 1979 and December 2011. There were 171 males (59.0%) and 119 females (41.0%). Median age was 63 years, range 1–87. Overall survival ranged from 0 to 383 months, with a median of 31 months. Five-year survival rate for patients who underwent liver resection for colorectal metastases was 35.8% (34/95). Discussion. Hepatic resections are safely performed at a low-volume centre, with regard to perioperative- and in-house mortality and 5-year survival rates.

scholarly journals Upfront docetaxel with androgen deprivation therapy in the elderly patient with metastatic hormone-naïve prostate cancer: Single institution experience.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 328-328 ◽  
Author(s):  
Lindsay Jennifer Andrew Rayner ◽  
Amarnath Challapalli ◽  
Eve Blackmore ◽  
Katherine Rea ◽  
Natasha Wells ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
The Elderly ◽  
Rank Test ◽  
Free Survival ◽  
Kaplan Meier ◽  
Elderly Cohort ◽  
Docetaxel Chemotherapy ◽  
Dose Reductions

328 Background: Following CHAARTED & STAMPEDE, upfront Docetaxel chemotherapy became standard of care for metastatic hormone-naïve prostate cancer (mHNPC). We sought to evaluate our experience in the elderly group of patients (>70 yrs) compared with the non-elderly cohort. Methods: A retrospective analysis was undertaken of 38 patients commenced on upfront docetaxel chemotherapy, from Jan 16 - Jan 17. Patients were stratified as low (LR) and high risk (HR), as per the LATITUDE study. Progression was defined as per PCWG-3 criteria. The progression free survival (PFS) was calculated as time from start of treatment to date of progression and analysed by Kaplan-Meier estimates and log-rank test. Rates of febrile neutropenia (FN) were also evaluated. Results: The median age was 69 (range: 53-80) yrs, with 50% (19/38) HR patients. The median PFS was 11.5m for progressors (P; 42%) and not reached for non-progressors (NP; 58%), (p<0.0001). Granulocyte colony stimulating factor (G-CSF) was used in 13/38 (34%) patients; these did not experience FN. The overall rate of FN was 20% where G-CSF was not used. Overall 31/38 (81.6%) completed 6 cycles of chemotherapy, with 26% requiring dose reductions (Table). Overall, of the 9/16 (56.3%) patients who progressed within 6m of completing docetaxel, 3 had Cabazitaxel as the next treatment (P: 2/3 (66.7%), median PFS 6.2m) and 6 had novel androgen receptor targeted therapy (P: 5/6 (83.3%), median PFS 3.3m). Conclusions: Upfront docetaxel is reasonably well tolerated in the elderly with comparable median PFS to younger patients. Use of GCSF significantly minimizes the risk of FN in this group and should be considered as standard of care. In patients who progress within 6m of completing docetaxel, we feel optimal sequencing to be Cabazitaxel followed by subsequent therapies.[Table: see text]

scholarly journals Clinical outcomes of doxorubicin-eluting CalliSpheres® beads-transarterial chemoembolization for unresectable or recurrent esophageal carcinoma

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yonghua Bi ◽  
Xiaonan Shi ◽  
Jianzhuang Ren ◽  
Mengfei Yi ◽  
Xinwei Han ◽  
...  
Keyword(s):  
Overall Survival ◽  
Esophageal Carcinoma ◽  
Clinical Outcomes ◽  
Transarterial Chemoembolization ◽  
Objective Response ◽  
Survival Rates ◽  
Progression Free Survival ◽  
Technical Success Rate ◽  
Primary Endpoints ◽  
Chemotherapy Infusion

Abstract Background The clinical outcomes of drug-eluting beads transarterial chemoembolization (DEB-TACE) with doxorubicin-loaded CalliSpheres® beads for patients with unresectable or recurrent esophageal carcinoma have not been reported. The aim of this study is to study the clinical outcomes of DEB-TACE for patients with unresectable or recurrent esophageal carcinoma. Methods This retrospective study enrolled 21 patients (15 men; mean age 68.7 ± 9.7; range 46–86 years) with unresectable or recurrent esophageal carcinoma received DEB-TACE between July 2017 and September 2020. Patient characteristic data, imaging findings, complications and DEB-TACE procedure were reviewed. The primary endpoints, disease control rate (DCR) and objective response rate (ORR), were calculated. The secondary endpoints were overall survival rate and progression-free survival (PFS). Results Twenty-two sessions of DEB-TACE were performed in 21 patients. The technical success rate was 100%; without sever adverse events or procedure-related deaths. All patients received transarterial chemotherapy infusion with raltitrexed or oxaliplatin. The median follow-up period was 3.6 months (interquartile range, IQR 1.5–9.4 months). ORR and DCR were 42.9 and 85.7%, 28.6 and 71.4%, 20.0 and 40.0% respectively at 1-, 3-, and 6-months after DEB-TACE. The median PFS was 6.0 months, and the 3-, 6- and 12-month PFS rates were 68.2%, 45.5 and 0.0%, respectively. The median overall survival was 9.4 months, and the 3-, 6- and 12-month overall survival rates were 75.5%, 55.0 and 13.8%, respectively. Conclusions To our knowledge, this is the first study reports outcomes of DEB-TACE with doxorubicin-loaded CallSpheres bead treatment in the management of patients with unresectable or recurrent esophageal carcinoma. According to our results, this is a safe and feasible treatment modality that may be considered among the options for the treatment of these patients.

scholarly journals Pembrolizumab Alone or Combined With Chemotherapy in Advanced NSCLC With PD-L1 ≥50%: Results of a Retrospective Study

2021 ◽  
Vol 11 ◽  
Author(s):  
Ya Chen ◽  
Yanan Wang ◽  
Zhengyu Yang ◽  
Minjuan Hu ◽  
Yanwei Zhang ◽  
...  
Keyword(s):  
Overall Survival ◽  
Advanced Nsclc ◽  
Survival Rates ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
Programmed Death ◽  
Platinum Based Chemotherapy ◽  
Prospective Trials ◽  
Nsclc Patients

ObjectivesPembrolizumab plus platinum-based chemotherapy and pembrolizumab monotherapy (PM) both become standard of care in patients with advanced non-small-cell lung cancer (NSCLC) and a programmed death ligand 1 (PD-L1) tumor proportion score (TPS) greater than 50%. This study aimed to figure out the better treatment choice.MethodIn this retrospective analysis, we compared the clinical efficacy of PM and PC as first-line treatment in NSCLC patients with a PD-L1 ≥50% and negative for genomic alterations in the EGFR and ALK genes.ResultAmong the population, 115 patients received PC, and 91 patients received PM. Up to Dec 30, 2020, median follow-up was 17.13 months. The median progression-free survival (PFS) rates of PC and PM were 12.37 and 9.60 months (HR: 0.44, p &lt; 0.001), respectively. The median overall survival (OS) rates were NE and 28.91 months (HR: 0.40, p = 0.005), respectively. Subgroup analysis found that the PFS benefit of PC was evident in most subgroups excepting patients with brain metastasis. The 1-year overall survival rates of PC and PM were 89.3% and 76.1%, respectively. The ORR was 61.7 and 46.9% (p = 0.004), respectively.ConclusionIn patients with previously untreated, PD-L1 ≥50%, advanced NSCLC without EGFR or ALK mutations, the addition of pembrolizumab to standard platinum-based chemotherapy seems to be the preferred treatment, which needs to be validated by further prospective trials.

scholarly journals Glioblastoma and increased survival with longer chemotherapy duration.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e13006-e13006
Author(s):  
Dory Abou-Jaoude ◽  
Joseph A Moore ◽  
Matthew B Moore ◽  
Philip Twumasi-Ankrah ◽  
Elizabeth Ablah ◽  
...  
Keyword(s):  
Sample Size ◽  
Retrospective Chart Review ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
Rank Test ◽  
Science Data ◽  
Chi Square ◽  
Log Rank Test ◽  
Kaplan Meier ◽  
Regional Referral Center

e13006 Background: The 5-year survival for patients (pts) with glioblastoma (GBM) is low at approximately 3%. Radiotherapy plus concomitant and adjuvant temozolomide (TMZ) remain the standard of care. The optimal duration of therapy with TMZ is unknown, though treatment periods of 6 months (mo), 12 mo and longer have been utilized. Whether or not there is a benefit with longer treatment duration is controversial. Methods: A retrospective chart review of all pts diagnosed with GBM who were treated at a regional referral center was conducted with data obtained from their electronic medical records. These pts were treated with TMZ for up to 2 years between January 1, 2002 and December 31, 2011. Survival was calculated as the time from initial surgical diagnosis until death. The Kaplan-Meier method with log-rank test was used to estimate the progression-free survival (PFS) as well as the overall survival (OS) distribution of pts after treatment. The results were compared to historical controls and data from previous clinical trials of pts treated up to 1 year. Results: Data from 56 pts were evaluated, the majority of whom had gross total resection and had external pathology review confirming the diagnosis of GBM. The OS probability was 55.4% (SE = 0.068) at 1 year, 26.9% (SE = 0.067) at 2 years and 20.1% (SE = 0.065) at 3 years. The median PFS time in this study group was 8 mo (95% CI = 4.0 – 9.0 mo). The probability of no progression at 2 years was 8.6% (SE = 0.05). Seven pts (12.5%) were treated with TMZ for 2 years. The probability of disease progression at 2 years among these pts was 33.3% with a median time-to-progression of 20 mo (95% CI = 5.0-28.0). These patients showed an increased survival probability at 3 years compared to pts who did not receive the 2 year treatment of TMZ (log-rank test Chi-square = 12.4, p = 0.0004). Conclusions: This analysis suggests that there may be an advantage for a longer duration of TMZ therapy in pts with GBM. In this review, treatment with TMZ for 2 years was associated with an increased survival benefit. While we consider the sample size to be too small for generalization, a prospective/multicenter study with a larger sample size might better evaluate the question of duration of TMZ therapy, particularly if both clinical and basic science data are paired.

Meningeal hemangiopericitoma (HPC): Treatment outcome in a retrospective series in a single institution.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e12511-e12511
Author(s):  
Alejandro Daniel Muggeri ◽  
BERNADETTE CALABRESE ◽  
Sebastian Cerrato ◽  
Andres Cervio ◽  
Blanca D. Diez
Keyword(s):  
Survival Rates ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
Rank Test ◽  
Subtotal Resection ◽  
Term Survival ◽  
Local Progression ◽  
Alive With Disease

e12511 Background: HPC is a rare malignant tumor with a high proclivity toward recurrence and metastasis. Methods: The purpose of this study was to analyse retrospectively a series of eighteen patients with HPC treated between January 1992 and Oct 2011 with respect to clinical presentation, treatment results and long-term follow-up outcomes.Survival rate and PFS were analyzed by Kaplan-Meier method, with the use of two-sided log-rank test statistics Results: Twelve were females with a median age of 44.5 years (21-62). In 17 the tumor was intracranial, in one in the spinal cord. Median follow-up was 75,5 months (4 -314). Eight underwent gross total resection (GTR) and 2 of them received adjuvant radiotherapy. Ten had subtotal resection (STR) and 2 of them received RT. Three of 6 with GTR without RT relapsed. All patients with STR suffered local progression (2 after RT). Five developed systemic metastases after reiterate surgical resection (more than 3); three of them are alive with disease after further treatment at 11, 18 and 28 month. The median progression free survival (PFS) was 42,5 months (4-264), with 2 and 5-year PFS rates of 88% and 27% respectively. The 2, 5 and 10-year survival rates was 100, 93 and 81% respectively. All patients with GTR are alive (median follow-up: 60,5 months, range 30-125) and 3 of 10 patients with STR died (median follow-up: 81,5 months, range 4-314). Conclusions: When safe and feasible, GTR should be pursued as an initial surgical strategy to maximize overall survival. Adjuvant RT may show promise in preventing tumor progression in GTR patients. In metastatic disease long term survival could be achieved. The lack of a standard of care for HPC patients makes it especially important to do a complete workup, especially among patients presenting with recurrent HPC.

Number of cycles of chemotherapy in patients with advanced non-small cell lung caner: Efficacy and relationship with histology.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e18125-e18125
Author(s):  
Eduardo Richardet ◽  
Martin Eduardo Richardet ◽  
Nicolas Castagneris ◽  
Matias Nicolas Cortes ◽  
Perelli Laura ◽  
...  
Keyword(s):  
Overall Survival ◽  
Stage Iv ◽  
Progression Free Survival ◽  
Rank Test ◽  
Test Results ◽  
First Line ◽  
Free Survival ◽  
Log Rank Test ◽  
Kaplan Meier ◽  
Number Of Cycles

e18125 Background: Platinum based regimens are standard first-line treatment in patients with advanced non mall cell lung cancer. We intend to evaluate their effectiveness according to the number of cycles administered, and investigate whether histology is a predictor of benefit from a greater number of infusions. Methods: 124 patients with stage IV NSCLC were evaluated retrospectively. They were divided according to whether they made 4 or 6 cycles of chemotherapy. The schemes used were: Cisplatin / Gemcitabine and Carboplatin / Paclitaxel, at standard doses. We studied the efficacy in both groups according to the most common histologies (adenocarcinoma and squamous cell carcinoma). PFS (progression-free survival) and OS (overall survival) were calculated by the Kaplan-Meier curves and compared by the Log Rank Test. Results: Those who underwent 4 cycles had a PFS of 7.77 months and OS of 12.2 months vs. 8.64 and 10.8 months those who received 6 cycles (p = 0.47, p = 0.76). Within the subgroup with squamous histology (n = 43), PFS and OS were 7.38 and 13.38 months respectively in the group that received 4 cycles vs. 7.97 and 9.76 months in those receiving 6 (p = 0.70, p = 0.32 ). Within adenocarcinoma histology (n = 81), those who received 4 cycle, has a PFS of 8.17 months and they lived 11.56 month, vs 8.96 and 10.79 months for those receiving 6 cycles (p = 0.29, p = 0.88) Conclusions: In our population, a greater number of cycles showed no advantages in terms of progression-free survival or overall survival. Histology is not a predictive factor for deciding how many chemotherapy cycles administer.

scholarly journals The epidemiology of uveal melanoma in Germany: a nationwide report of incidence and survival between 2009 and 2015

2021 ◽  
Author(s):  
Ahmad Samir Alfaar ◽  
Anas Saad ◽  
Peter Wiedemann ◽  
Matus Rehak
Keyword(s):  
Overall Survival ◽  
Uveal Melanoma ◽  
Survival Rates ◽  
Incidence Rates ◽  
Rank Test ◽  
German Population ◽  
Cancer Specific Survival ◽  
Incidence Data ◽  
Kaplan Meier ◽  
Melanoma Subtypes

Abstract Purpose To calculate the overall incidence of uveal melanoma in Germany and to compare incidences in different German states. In addition, we computed the overall and cancer-specific survival rates nationwide. Methods Incidence data for the period between 2009 and 2015, covering the entire German population, was collected through the German Center for Cancer Registry. ICD-O-3 topography codes C69.3-C69.4 and histology codes for melanoma subtypes were used to collect the incidence data. Confidence Intervals with a level of 95% (95% CI) were calculated for rates. Survival was calculated using the Kaplan–Meier. The log-rank test was used for survival comparisons. Results This study comprised 3654 patients with uveal melanomas, including 467 (12.8%) with iridial and ciliary body tumors. The overall age-standardized incidence rate (ASIR) was 6.41 person per million. Generally, the ASIR was higher in males than females (6.67 (95% CI 6.37–6.98) vs. 6.16 (95% CI 5.88–6.45 per million). Higher crude incidence rates were noted in the northeastern states (12.5 per million (95% CI 10.5–14.7) in Mecklenburg-Vorpommern) compared with the southwestern states (2.1 per million (95% CI 1.7–2.6) in Hessen). The 5-year overall survival stood at 47%, while the cancer-specific survival stood at 84%. Multivariate analysis showed that women, younger patients, and patients living in Berlin achieved significantly higher overall survival. Conclusion Overall ASIR of uveal melanoma in Germany indicates that the disease is more common in males and that it follows the same geographical distribution previously noted in central European countries, with the highest incidence in northern parts of Germany.

Concurrent chemoradiotherapy for unresectable hilar choloangiocarcinoma: A single-institution experience.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 326-326
Author(s):  
P. Hunag ◽  
Y. Chao ◽  
C. Li ◽  
R. Lee ◽  
L. Wang ◽  
...  
Keyword(s):  
Hilar Cholangiocarcinoma ◽  
Survival Rates ◽  
Progression Free Survival ◽  
Distant Metastases ◽  
Rank Test ◽  
Combined Modality Treatment ◽  
Klatskin Tumor ◽  
Single Institution ◽  
Kaplan Meier ◽  
Rare Malignancy

326 Background: Hilar cholangiocarinoma (Klatskin tumor) is a rare malignancy which is best managed with surgical resection. The majority of patients, however, is unresectable at the time of diagnosis and generally has a poor outcome. The purpose of this study was to retrospectively evaluate the role of chemoradiotherapy (CCRT) for patients with unresectable hilar choloangiocarcinoma at a single institution. Methods: Between 2001 and 2008, a total of 33 patients with unresectable, nonmetastatic hilar cholangiocarcinoma treated at Taipei Veterans General Hospital were reviewed. All patients were to receive 3D-CRT with a median dose of 50.4 Gy (range, 39.6- 60) at 1.8-2 Gy per fraction per day. Sixteen patients also received bolus 5-fluorouracil (5-FU) CCRT (500 mg/m2/d for 3 days repeated every 2 weeks during radiotherapy for 6 weeks). Survivals were estimated by the Kaplan-Meier method and compared by log-rank test. Results: There were 21 males and 12 females, with a median age of 71 years (range, 29 - 81). The median follow-up time was 10.4 months (range, 1 – 42.3) for all patients with the 1- and 2-year survival rates of 45% and 12%, respectively. The median overall survival (OS) and progression-free survival (PFS) were 13.5 months and 10.2 months for the CCRT group, and 10.4 months and 6.5 months for the RT alone group (p = 0.36 and p = 0.28, respectively). Adverse events were similar in thetwo groups with 14 patients (42%) developed grade 1-2 gastrointestinal toxicity during RT. Locoregional progression was observed in 26 patients (79%) and distant metastases in 9 patients (27%). All patients experienced disease progression and had died at time of analysis. Conclusions: The outcome remains poor for unresectable hilar cholangiocarcinoma despite aggressive combined modality treatment. Although not statistically significant, our data showed CCRT provides longer OS and PFS in patients with unresectable hilar cholangiocarcinoma compared to RT alone. Locoregional progression is the main problem for this disease and the efficacy of adding chemotherapy or biologic agents needs to be further investigated. No significant financial relationships to disclose.

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