scholarly journals Correlations of survival with progression-free survival, response rate, and disease control rate in advanced biliary tract cancer: a meta-analysis of randomised trials of first-line chemotherapy

2016 ◽  
Vol 114 (8) ◽  
pp. 881-888 ◽  
Author(s):  
Toshikazu Moriwaki ◽  
Yoshiyuki Yamamoto ◽  
Masahiko Gosho ◽  
Mariko Kobayashi ◽  
Akinori Sugaya ◽  
...  
2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Hongqiong Yang ◽  
Yaojun Zhou ◽  
Liangzhi Wang ◽  
Tianyi Gu ◽  
Mengjia Lv ◽  
...  

Five electronic databases were searched for eligible records. Outcomes were presented and analyzed according to the objective response rate (ORR), progression-free survival (PFS) rate, and overall survival (OS) rate. Five records involving 2,024 participants were included in the study. The pooled analysis of OS and PFS were longer with ramucirumab (RAM) therapy than without RAM for OS (odds ratio OR = 0.90 , 95% confidence interval CI = 0.82 – 1.00 , p = 0.05 ) and PFS ( OR = 0.74 , 95 % CI = 0.57 – 0.96 , p = 0.02 ). Moreover, compared with the current first-line chemotherapy, the OS ( OR = 0.93 , 95 % CI = 0.83 – 1.04 , p = 0.19 ) and PFS ( OR = 0.82 , 95 % CI = 0.64 – 1.06 , p = 0.13 ) results were not significantly higher with RAM. The ORRs of the patients in the RAM therapy groups were significantly higher than those in the groups without RAM ( OR = 1.40 , 95 % CI = 1.14 – 1.73 , p = 0.001 ).


2019 ◽  
Vol 26 (6) ◽  
pp. 1331-1342
Author(s):  
Irena Ilic ◽  
Sandra Sipetic ◽  
Jovan Grujicic ◽  
Milena Ilic

Introduction Almost half of patients with non-small-cell lung cancer (NSCLC) are diagnosed at an advanced stage. Our aim was to assess the effects of adding necitumumab to chemotherapy in patients with stage IV NSCLC. Material and methods A comprehensive literature search was performed according to pre-specified inclusion and exclusion criteria. Data on overall survival, progression-free survival, objective response rate and adverse events were extracted. A meta-analysis was performed to obtain pooled hazard ratios (HR) and corresponding 95% confidence intervals (CI) for time-to-event data and pooled odds ratio (OR) with 95% CI for dichotomous outcomes. Results The meta-analysis included four randomized clinical trials with 2074 patients. The pooled results showed significant improvement for overall survival (HR = 0.87 (95% CI 0.79–0.95), p = 0.004) when necitumumab was added to chemotherapy in patients with advanced NSCLC. No statistically significant improvement was noted for progression-free survival and objective response rate (HR = 0.83 (95% CI 0.69–1.01), p = 0.06 and OR = 1.46 (95% CI 0.90–2.38), p = 0.13, respectively). Subgroup analysis showed that in patients with non-squamous NSCLC, there was no benefit in overall survival and objective response rate. Patients with advanced NSCLC who received necitumumab were at the highest odds of developing a skin rash (OR = 14.50 (95% CI 3.16–66.43), p = 0.0006) and hypomagnesaemia (OR = 2.77 (95% CI 2.23–3.45), p < 0.00001), while the OR for any grade ≥3 adverse event was 1.55 (95% CI 1.28–1.87, p < 0.00001). Conclusions The addition of necitumumab to standard chemotherapy in a first-line setting in patients with stage IV NSCLC results in a statistically significant improvement in overall survival, while the results were not significant for progression-free survival and objective response rate.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 4120-4120
Author(s):  
Nobumasa Mizuno ◽  
Juan W. Valle ◽  
Junji Furuse ◽  
Mark Jitlal ◽  
Sandy Beare ◽  
...  

4120 Background: Two recent randomised studies (ABC-02 [UK] and BT22 [Japan]) have demonstrated the superiority of cisplatin and gemcitabine (CisGem) chemotherapy over gemcitabine (Gem) alone for patients with pathologically-proven advanced biliary tract cancer (BTC: cholangiocarcinoma, gallbladder and ampullary cancers). Methods: We performed a meta-analysis of individual patient-level data of these studies to establish the effect of CisGem vs. Gem on progression-free survival (PFS), overall survival (OS) and performed exploratory sub-group analyses. Results: A total of 493 patients, median age 64 years (range 23-84 years) with approximately equal sex distribution, were randomised (ABC-02 study n=410; BT22 study n=83) to receive either CisGem (n=245) or Gem (n=248). CisGem demonstrates a significant improvement in PFS (hazard ratio (HR)=0.64 (95%-CI: 0.53-0.76), p<0.001) and OS (HR=0.65 (95%-CI: 0.54-0.78), p<0.001) over Gem. This effect is most marked in patients with good performance status (PS 0-1): HR for PFS is 0.61 (95%-CI: 0.51-0.74), p<0.001 and HR for OS is 0.64 (95%-CI: 0.53-0.77), p<0.001. CisGem resulted in improved PFS and OS for intra- and extra-hepatic cholangiocarcinomas and gallbladder cancer. The treatment effect between UK and Japanese patients was consistent with respect to OS (HR=0.65, 95%-CI 0.53–0.79 and 0.65, 95%-CI 0.42–1.03, respectively); with similar median survival in the combination arms (median 11.7 and 11.1 months, respectively). Subgroups least likely to benefit included patients with ampullary tumours and poor performance score (PS2). Conclusions: CisGem is the standard of care for the first-line treatment of good-PS patients with advanced BTC regardless of ethnicity. Future studies should aim to enhance the effectiveness of this regimen in the first-line setting and establish the role of subsequent (second-line) therapy. Clinical trial information: ABC-02: NCT00262769, BT22; NCT00380588.


2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 334-334
Author(s):  
Lars Henrik Jensen ◽  
Anne Haahr Mellergaard ◽  
Dan Hoegdall ◽  
Ole Larsen

334 Background: Since 2010, the doublet gemcitabine and cisplatin has been standard first-line systemic treatment for non-resectable biliary tract cancer. In a phase I-II trial of the well-tolerated triplet of gemcitabine, oxaliplatin, and capecitabine, the median progression free survival (PFS) and overall survival (OS) were 6.9 and 12.5 months, respectively. Overall response rate was 34%. Since 2005 the regimen has been used in Denmark. We wanted to investigate the effectiveness of the triplet regimen given in daily clinic. Methods: We included 192 patients from two institutions. Patients had to have non-resectable biliary tract cancer and to be suitable for combination chemotherapy on doctor’s discretion. Gemcitabine 1000 mg/m2 and oxaliplatin 60 mg/m2 were given every two weeks followed by capecitabine 1000 mg/m2 b.i.d. for one week. At one institution the oxaliplatin dose was 50 mg/m2 and capecitabine dose 650 mg/m2 b.i.d. continuously. One cycle included two treatments and was typically administered for up to six cycles/months, but was allowed for longer time until progression. Results: At institution A, 117 patients were included and 73 (62%) were women. Median age was 66 years (range 25-80). Median treatment duration was six cycles/months (range 1-12). Thirty-five, 69, 12, and one patient(s) were in performance status 0, 1, 2, and 3, respectively. Ninety patients were evaluable for response and 6 (7%) had complete response, 18 (20%) partial response, 53 (59%) stable disease, and 13 (14%) progression as best response. Median PFS was 9.7 months (95% CI 8.5-11.7) and median OS 11.7 months (9.8-14.0). The results were comparable to institution B, where the response rate in 56 patients with measurable disease was 30%. In 75 patients evaluable for survival analysis, PFS was 8.1 months and OS 12.0 months for performance status 0-1 (n=55). Patients in performance status 2 (n=25) had a PFS and OS of only 1.7 and 2.8 months, respectively. Conclusions: A triplet of gemcitabine, oxaliplatin, and capecitabine given in daily clinic was well tolerated and has effectiveness comparable to results from a phase II trial and the pivotal phase III trial of gemcitabine and cisplatin.


Author(s):  
Hong Chuyen Nguyen Thi

Purpose:to study clinical and subclinical characteristics in advanced stage gastric cancer patients and to evaluate response rate, overall survival, progression free survival and toxicities on advanced stage gastric cancer patients treated with first line chemotherapy using epirubicin, oxaliplatin, capecitabin Methods: A retrospective case series study with 134 advanced stage gastric cancer patients on first line chemotherapy using epirubicin, oxaliplatin, capecitabin recruited from oncology department, the Hospital of Hue University of Medicine and Pharmacy and Cancer Center at Hue Central Hospital during January 2015 to June 2019. Results: Patient’s mean age was 54,9; men/women was 2,52/1. The most frequent clinical symptom reported was epigastric pain 81,3%. KPS 80-90% presented in almost patient (93.3%). The most common site of cancer was pyloric antrum (61,9%). 58,2% patients had distant metastasis disease which liver was the most frequent site. The overall response rate, partial response rate, complete response rate were 49,2%, 42,5%, 6,7% respectively. The median progression free survival was 8,6 ± 0,15 months and the overall survival was 10,7 ± 1,1 months. The pathologic type and combined salvage surgery status were response correlated factors. Grade 3, 4 toxicities in term of hematology, liver and kidney function were only exhibited in a few cases. Patients were tolerated well with chemotherapy. No deaths related to chemotherapy. Conclusions: This study shows that EOX regimen was safe and effective. As a results, we can apply this for first line pallative chemotherapy on advanced stage gastric cancer which KPS ≥70%.


1999 ◽  
Vol 17 (7) ◽  
pp. 2069-2069 ◽  
Author(s):  
P. A. Vasey ◽  
J. Paul ◽  
A. Birt ◽  
E. J. Junor ◽  
N. S. Reed ◽  
...  

PURPOSE: A prospective, nonrandomized, multicenter, open feasibility study of cisplatin and docetaxel as first-line chemotherapy in International Federation of Gynecology and Obstetrics (FIGO) stage IC-IV epithelial ovarian cancer was conducted. The primary end point was the incidence of severe fluid retention that necessitated treatment withdrawal. PATIENTS AND METHODS: Cisplatin and docetaxel were administered every 3 weeks for six planned cycles, with a 5-day prophylactic dexamethasone regimen (8 mg two times per day). One hundred patients (median age, 53 years; range, 24 to 71 years) received a total of 512 cycles of chemotherapy in two cohorts: cohort 1, 49 patients, 258 cycles (cisplatin 75 mg/m2 and docetaxel 75 mg/m2); cohort 2, 51 patients, 254 cycles (cisplatin 75 mg/m2 and docetaxel 85 mg/m2). RESULTS: No patients were taken off study because of fluid retention. Sixty-six patients completed six cycles of protocol therapy; 16 stopped early because of toxicity (neurotoxicity in six patients, nephrotoxicity in three, neutropenia in two, and hypersensitivity, diarrhea and vomiting, skin rash, clinical deterioration, and patient's wishes in one patient each). Grade 3/4 neutropenia was observed in more than 75% of patients and seemed to be cumulative. Patients in cohort 2 had significantly more severe neutropenia and lethargy than those in cohort 1. In addition, there were five treatment-related deaths in cohort 2 (three neutropenia and two upper gastrointestinal hemorrhage). Neurotoxicity (mainly sensory, > grade 1) was observed in 23 patients. The overall clinical response rate was 69% (complete response, 38%; partial response, 31%); CA-125 response rate was 73%. Median progression-free survival for the group was 12 months. CONCLUSION: Cisplatin and docetaxel can be administered at doses of 75 mg/m2 and 75 mg/m2, respectively, every 3 weeks, and the utility of this regimen is not limited by fluid retention. However, 33 of 100 patients were unable to complete the planned six cycles, which may explain, in part, the poor overall progression-free survival. Increasing the docetaxel dose to 85 mg/m2 adds unacceptable hematologic toxicity and potential risks to the patient.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e15132-e15132
Author(s):  
Jangho Cho ◽  
Jae Yun Lim ◽  
Jae Yong Cho

e15132 Background: Gemcitabine is the standard treatment for advanced pancreatic cancer. Though capecitabine and erlotinib are accepted as combination agent with gemcitabine, those two combination regimens have not been compared directly in clinical trial. This study compared the efficacy and tolerability between gemcitabine plus capecitabine (GEM-X), gemcitabine plus erlotinib (GEM-T), and gemcitabine monotherapy (GEM) as first-line chemotherapy in patients with advanced pancreatic cancer. Methods: We collected data ofpatients if they met the following criteria: histologically or cytologically confirmed ductal adenocarcinoma of the pancreas; unresectable/metastatic disease; treated with one of GEM, GEM-X, and GEM-T as first-line treatment; measurable or evaluable lesion; age more than 18 years; Eastern Cooperative Oncology Group performance status 0, 1, or 2; and adequate hematologic, hepatic, and renal function before first-line chemotherapy. Response rate, progression-free survival (PFS), overall survival (OS), and toxicity were evaluated. Results: Between January 2007 and November 2011, a total of 127 patients received one of GEM (n=47), GEM-T (n=44), and GEM-X (n=36). GEM-X significantly improved the objective response rate (21.2% vs. 12.7% and 15.9%), progression-free survival (8.9 vs. 5.2 and 3.9 months; p < 0.001) and OS (12.1 vs. 10.4 and 9.9 months; p = 0.03) compared to GEM and GEM-T, respectively. The incidence of adverse events was not significantly different among groups. Conclusions: GEM-X presented better clinical efficacy and acceptable tolerability than GEM-T and GEM in locally advanced and metastatic pancreatic cancers. It is worthy to further investigate which agent has clinical advantage as combination drug with gemcitabine in pancreatic cancer and to explore predictive markers for each regimen leading to personalize anti-cancer treatment.


2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 356-356 ◽  
Author(s):  
Kei Saito ◽  
Masato Ozaka ◽  
Ryo Kanata ◽  
Ikuhiro Yamada ◽  
Takashi Sasaki ◽  
...  

356 Background: FOLFIRINOX is the first-line chemotherapy for patients with unresectable pancreatic cancer and yielded a longer overall survival, a superior progression-free survival, a higher objective response rate compared with gemcitabine alone. Maximum tumor shrinkage of primary site (MTSP) was associated with the survival outcome in colon cancer. However the data of tumor shrinkage in pancreatic cancer has not been well-documented. Therefore, we re-evaluated FOLFIRINOX focusing on the tumor shrinkage of primary site. We also assessed impact of tumor shrinkage on survival of unresectable pancreatic cancer. Methods: Medical records were retrospectively reviewed for consecutive patients receiving FOLFIRINOX as the first-line chemotherapy between January and December 2014. Response was evaluated by CT scan every 2 or 3 months until the end of treatment. We analyzed patients’ characteristics and rate of MTSP related to overall survival (OS) and progression free survival (PFS). Results: Thirty one patients were analyzed: median age of 62, male gender in 64.5%, performance status of 0 in 90.3%, metastatic cancer in 58.1%, the head of cancer in 41.9%, the UGT1A1 wild type in 48.4%, overall response rate in 25.8%. PFS was 7.7 months (95%CI: 6.57-9.6). Rate of MTSP were 18.8% (locally 18.8%, metastatic 18.1%) and rate of GRs/non-GRs/non-R (GRs (Good responders) were defined as patients whose MTSP were more than 20% and non-GRs (non-Good responders) were less than 20%) were 45.2%/35.5%/19.3%. PFS was 9.0(95%CI, 6.7- ) months in GRs, compared with 6.9(95%CI, 3.6-10.2) months in non-GRs (p = 0.15). Conclusions: MTSP by FOLFIRINOX could not affect PFS of pancreatic cancer.


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