Oral capecitabine in gemcitabine-pretreated patients with advanced pancreatic cancer: A single-center study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 15085-15085 ◽  
Author(s):  
S. H. Boeck ◽  
R. Wilkowski ◽  
C. J. Bruns ◽  
R. D. Issels ◽  
C. Schulz ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Treatment Regimen ◽  
Single Agent ◽  
Advanced Pancreatic Cancer ◽  
Previous Treatment ◽  
Median Number ◽  
Salvage Chemotherapy ◽  
Standard Regimen ◽  
Hand Foot Syndrome ◽  
Grade 3

15085 Background: To date, no standard regimen for salvage chemotherapy after gemcitabine (Gem)-failure is defined in patients with advanced pancreatic cancer (PC). Methods: Within this study we prospectively collected clinical data of 37 patients (pts) with advanced PC who were treated with capecitabine (Cape) at our center. Cape was offered to patients who already had received at least one previous treatment regimen containing full-dose Gem (either as single- or combination chemotherapy or sequentially within a radio- chemotherapy (RCT) protocol), who presented with a KPS = 70% and had adequate organ function. Cape was administrated orally at a daily dose of 2 x 1250 mg/m2 for 14 consecutive days followed by 7 days of rest (in pts > 65 years: 2 x 1000 mg/m2/d). Treatment cycles were repeated every 3 weeks and continued until disease progression or unacceptable toxicity. Results: A median number of 3 treatment cycles (range 1–36) was given to 37 pts (54% male, median age 63 yrs, 97% with metastatic disease); 15 pts previously underwent RCT, 20 pts had received one previous treatment regimen and 17 pts 2 or more previous regimens. After a median follow- up of 6.1 months, 10 pts are still alive including 4 pts still on Cape. Currently, 35 pts are evaluable for response: no complete or partial response was observed, but 13 pts (37%) had stable disease (SD). A CA19–9 reduction > 20% after 8 weeks of Cape was determined in 6 pts (16%), all of them had SD. Median TTP was 2.2 months, median overall survival (since start of Cape treatment) was 7.5 months. Predominant grade 2 and 3 toxicities (per patient analysis) were: hand-foot-syndrome 30%, anemia 24%, diarrhea 14%, nausea/vomiting and leukopenia 11% each. One pt had a grade 3 infection, 1 pt experienced grade 4 cerebral ischemia during treatment with Cape. Conclusion: Single-agent Cape is a safe treatment option for Gem-pretreated pts with advanced PC. The disease control rate of 37% and a median TTP of 2.2 months appear interesting in this patient population. Further evaluation of Cape in controlled clinical trails is recommended in Gem-refractory pts with advanced PC. No significant financial relationships to disclose.

Irinotecan monotherapy as second-line treatment in advanced pancreatic cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 15111-15111 ◽  
Author(s):  
Y. Park ◽  
S. Yi ◽  
H. Kim ◽  
S. Lee ◽  
I. Hwang ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Stable Disease ◽  
Single Agent ◽  
Advanced Pancreatic Cancer ◽  
Median Number ◽  
Line Treatment ◽  
Second Line ◽  
Best Response ◽  
Grade 3 ◽  
Number Of Cycles

15111 Background: The aim of this phase II study was to determine whether second line therapy with single agent irinotecan could provide any clinical benefit in patients with gemcitabine- pretreated advanced pancreatic cancer. Methods: From January 2004 to October 2006, patients with advanced pancreatic cancer previously treated with gemcitabine alone or combination were treated with single agent irinotecan(150 mg/m2, biweekly), until unacceptable toxicity or disease progression. Primary endpoint was response rate with single stage design. Results: Twenty-eight patients were enrolled(22 male, 6 female, median age : 54.5 years (39–76)). Nine patients are still alive and 3 remain on therapy with stable disease. The median number of cycles was 3.5(1–12). Twenty-four patients were assessable for toxicity and 21 for response. The most common toxicities was diarrhea (grade 3, 12.5%). Grade 3 neutropenia in 1 patient was observed. Other hematological and non-hematological toxicities were mild and manageable. Partial responses were observed in 3 patients (3/21, 14%). An additional 9 patients (9/21, 43%) had stable disease as their best response. 12 patients have progressed with a median time-to-progression of 4.0 months. Conclusions: Single-agent irinotecan was tolerated with manageable toxicity, offering encouraging activity as second-line treatment of patients with advanced pancreatic cancer, refractory to gemcitabine. No significant financial relationships to disclose.

Gemcitabine Plus Capecitabine Compared With Gemcitabine Alone in Advanced Pancreatic Cancer: A Randomized, Multicenter, Phase III Trial of the Swiss Group for Clinical Cancer Research and the Central European Cooperative Oncology Group

2007 ◽  
Vol 25 (16) ◽  
pp. 2212-2217 ◽  
Author(s):  
Richard Herrmann ◽  
György Bodoky ◽  
Thomas Ruhstaller ◽  
Bengt Glimelius ◽  
Emilio Bajetta ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Performance Status ◽  
Single Agent ◽  
Advanced Pancreatic Cancer ◽  
Phase Iii ◽  
Metastatic Pancreatic Cancer ◽  
Karnofsky Performance Score ◽  
Phase Iii Trial ◽  
Good Performance Status ◽  
Grade 3

PurposeThis phase III trial compared the efficacy and safety of gemcitabine (Gem) plus capecitabine (GemCap) versus single-agent Gem in advanced/metastatic pancreatic cancer.Patients and MethodsPatients were randomly assigned to receive GemCap (oral capecitabine 650 mg/m2twice daily on days 1 to 14 plus Gem 1,000 mg/m2by 30-minute infusion on days 1 and 8 every 3 weeks) or Gem (1,000 mg/m2by 30-minute infusion weekly for 7 weeks, followed by a 1-week break, and then weekly for 3 weeks every 4 weeks). Patients were stratified according to center, Karnofsky performance score (KPS), presence of pain, and disease extent.ResultsA total of 319 patients were enrolled between June 2001 and June 2004. Median overall survival (OS) time, the primary end point, was 8.4 and 7.2 months in the GemCap and Gem arms, respectively (P = .234). Post hoc analysis in patients with good KPS (score of 90 to 100) showed a significant prolongation of median OS time in the GemCap arm compared with the Gem arm (10.1 v 7.4 months, respectively; P = .014). The overall frequency of grade 3 or 4 adverse events was similar in each arm. Neutropenia was the most frequent grade 3 or 4 adverse event in both arms.ConclusionGemCap failed to improve OS at a statistically significant level compared with standard Gem treatment. The safety of GemCap and Gem was similar. In the subgroup of patients with good performance status, median OS was improved significantly. GemCap is a practical regimen that may be considered as an alternative to single-agent Gem for the treatment of advanced/metastatic pancreatic cancer patients with a good performance status.

scholarly journals Systematic review and meta-analysis of gemcitabine-based chemotherapy after FOLFIRINOX in advanced pancreatic cancer

2020 ◽  
Vol 12 ◽  
pp. 175883592090540 ◽  
Author(s):  
Victor H. F. de Jesus ◽  
Marcos P. G. Camandaroba ◽  
Vinicius F. Calsavara ◽  
Rachel P. Riechelmann
Keyword(s):  
Systematic Review ◽  
Pancreatic Cancer ◽  
Pancreatic Adenocarcinoma ◽  
Meta Analysis ◽  
Single Agent ◽  
Objective Response ◽  
Advanced Pancreatic Cancer ◽  
Eligibility Criteria ◽  
Grade 3 ◽  
Advanced Pancreatic Adenocarcinoma

Background: There are no randomized data to guide treatment decisions for patients with advanced pancreatic adenocarcinoma following first-line FOLFIRINOX. We performed a systematic review and meta-analysis of studies using gemcitabine-based chemotherapy after FOLFIRINOX to assess treatment efficacy and toxicity. Methods: We included studies published between 2011 and 2018 that evaluated the efficacy and toxicity of gemcitabine-based chemotherapy after FOLFIRINOX in patients with advanced pancreatic adenocarcinoma. We searched PubMed, Embase, Scopus, and Web of Science. Primary outcomes were objective response rate (ORR), disease control rate (DCR), any grade 3/4 toxicity rate, and progression-free survival (PFS). We used the random-effects model to generate pooled estimates for proportions. Results: Sixteen studies met the eligibility criteria. Overall, ORR was 10.8%, DCR was 41.1%, and any grade 3/4 toxicity rate was 28.6%. In subgroup analyses, gemcitabine plus nab-paclitaxel was associated with superior ORR (14.4 versus 8.4%; p = 0.038) and DCR (53.5 versus 30.5%; p < 0.001) compared with single-agent gemcitabine. Median PFS ranged from 1.9 to 6.4 months and numerically favored gemcitabine plus nab-paclitaxel. Conclusions: Our study suggests gemcitabine-based chemotherapy likely outperforms best supportive care after FOLFIRINOX in advanced pancreatic cancer. Also, gemcitabine plus nab-paclitaxel seems to be more active than single-agent gemcitabine (CRD42018100421).

Phase II study of alternate-day oral therapy with S-1 for unresectable advanced pancreatic cancer: An updated report.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 252-252
Author(s):  
Sohei Satoi ◽  
Motoki Miyazawa ◽  
Masaji Tani ◽  
Manabu Kawai ◽  
Seiko Hirono ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Adverse Effects ◽  
Phase Ii ◽  
Primary Endpoint ◽  
Advanced Pancreatic Cancer ◽  
Progression Free Survival ◽  
Final Analysis ◽  
Current Data ◽  
Standard Regimen ◽  
Grade 3

252 Background: Based on the results of GEST, S-1 was confirmed to be non-inferior to gemcitabine. However, the recommended regimen of 4 weeks of administration interrupted by 2 weeks of drug withdrawal frequently causes adverse effect. Grade3/4 toxicities (%) in S-1 were neutropenia 8.8, anorexia 11.4, diarrhea 5.5. On the other hand, we experienced in clinical practice that the alternate-day administration of S-1 reduced adverse effects and was tolerable for unresectable advanced pancreatic cancer patients unwilling to continue the standard daily administration. We therefore conducted a multi-center cooperative prospective study to compare daily with alternate-day administration of S-1 for unresectable advanced pancreatic cancer. Methods: Patients with unresectable advanced pancreatic cancer (PS, 0 to 1; age, 20 to 80 years; no other therapy) were eligible for enrollment in this trial. S-1 was administered a dose of 40 to 60 mg twice daily, assigned according to body-surface area, on Monday, Wednesday, Friday, and Sunday (specified days). Each treatment cycle will be 42 days (6 weeks). The primary endpoint was overall survival (OS). Secondary endpoints were safety, response rate (RR), progression free survival (PFS), time to treatment failure (TTF). Results: A total of 50 patients were enrolled from Sep 2009 to Feb 2011. 48 patients were evaluable for response. Male/Female was 21/27, PS: 0/1 was 40/8. With a median follow-up time of 28.2 months, OS as primary endpoint was 8.4 months (95% CI, 5.4-10.8) with the 1 year survival rate 29.2%. PFS was 5.5 months, and TTF was 3.9 months. RR was 10.4% (95% CI: 3.5-19.1), and Disease Control rate was 79.2%. Grade 3/4 hematological and non-hematological toxicities were minor. All of those adverse reactions were tolerable and reversible. Conclusions: We will report the data from the final analysis at this meeting. The current data show mitigation of adverse effects with alternate-day administration of S-1, and it appears to be a more sustainable option for unresectable advanced pancreatic cancer. A randomized phase II trial comparing this regimen of S-1 with standard regimen of S-1 is ongoing. Clinical trial information: 000003453.

Single agent of apatinib in patients with recurrent or refractory cervical cancer: A real-world multicenter retrospective study.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e17011-e17011
Author(s):  
Ning Li ◽  
Ziyi Wang ◽  
Jing Wang ◽  
Lingying Wu
Keyword(s):  
Cervical Cancer ◽  
Retrospective Study ◽  
Single Agent ◽  
Previous Treatment ◽  
Progression Free Survival ◽  
Chinese Patients ◽  
Medical Sciences ◽  
Cancer Hospital ◽  
Hand Foot Syndrome ◽  
Grade 3

e17011 Background: Few effective treatment strategy has been established for patients with recurrent or refractory cervical cancer. The present study evaluates the efficacy and safety of apatinib single agent in Chinese patients with recurrent or refractory cervical cancer. Methods: Records of patients with cervical cancer treated from October 1, 2016 to December 31, 2017 in Cancer Hospital, Chinese Academy of Medical Sciences and Hunan Cancer Hospital were reviewed. Patients who met the following criteria were included: 1) patients had pathologically confirmed cervical cancer; 2) patients who experienced progression within 6 months or during previous treatment; 3) patients were given 250 mg apatinib daily for the present recurrence; 4) medical records were complete for evaluation of efficacy and toxicity. Tumor response was determined according to RECIST 1.1. The toxicity was determined according to CTCAE 4.0. SPSS 20.0 was adopted for statistic analysis. The primary endpoint was progression-free survival (PFS). Results: Twenty-nine patients were enrolled in our retrospective study. The clinical characteristics were shown in table 1. Thirteen patients (44.8%) had persistent disease and the other 16 patients (55.2%) had recurrent disease less than 6 months after the last treatment. Up to February 1, 2018, the median follow-up time was 8 months. Five (17.2%) patients achieved partial response, and 11 (37.9%) achieved stable disease, representing a disease control rate of 55.1%. The median PFS was 4 months (1-16 months). Nine patients were still on medication. The reasons of discontinued intervention were disease progression (80.0%, 16/20), toxicity (10.0%, 2/20) and other events unrelated with apatinib (10.0%, 2/20). Common adverse events were hypertension (G1, 65.5%), mucositis (G1, 55.2%), hand-foot syndrome (G1-2, 44.8%) and proteinuria (G1-2, 20.7%). Grade 3 proteinuria occurred in 1 patient (3.4%,). Conclusions: Apatinib single agent might be an effective and tolerable choice for patients with recurrent or refractory cervical cancer. Further study is warranted.[Table: see text]

Treatment of Pancreatic Cancer With Docetaxel and Granulocyte Colony-Stimulating Factor: A Multicenter Phase II Study

1999 ◽  
Vol 17 (6) ◽  
pp. 1779-1779 ◽  
Author(s):  
Nikos Androulakis ◽  
Charalambos Kourousis ◽  
Meletios A. Dimopoulos ◽  
George Samelis ◽  
Stelios Kakolyris ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Performance Status ◽  
Single Agent ◽  
Advanced Pancreatic Cancer ◽  
Complete Response ◽  
World Health ◽  
Granulocyte Colony Stimulating Factor ◽  
Colony Stimulating Factor ◽  
Grade 3 ◽  
Stimulating Factor

PURPOSE: To determine the efficacy and tolerance of single-agent docetaxel and granulocyte colony-stimulating factor in patients with advanced pancreatic cancer. PATIENTS AND METHODS: Thirty-three chemotherapy-naive patients (median age, 65 years) with histologically confirmed pancreatic cancer were treated, after appropriate premedication, with docetaxel (100 mg/m2) and granulocyte colony-stimulating factor (150 μg/m2/d subcutaneously days 2 through 10) every 3 weeks. World Health Organization performance status was 0 to 1 in 28 patients (85%) and 2 in 5 patients (15%). Twenty-nine patients had stage III and IV disease. RESULTS: One complete response (3%) and one partial response (3%) were observed for an overall response rate of 6% (95% confidence interval, 2.1% to 14.2%). Nineteen patients (58%) had stable disease and 12 (36%) had progressive disease. The duration of the two objective responses was 10 and 28 weeks, and the median time to tumor progression was 20 weeks. The median overall survival was 36 weeks. The actuarial 1-year survival was 36.4%. The performance status improved in seven of 21 assessable patients (24%) and pain improved in 14 of 21 (67%) assessable patients; five patients (29%) experienced weight gain during treatment. Disease-related asthenia, anorexia, vomiting, and diarrhea improved in 29%, 15%, 67%, and 47% of the assessable patients, respectively. Serum concentrations of CA 19-9 were decreased by more than 50% in seven patients (35%). Grade 3 and 4 neutropenia occurred in four patients (12%) and eight patients (24%), respectively, with two episodes of febrile neutropenia. There were no treatment-related deaths. Grade 3/4 asthenia occurred in three patients. CONCLUSION: Although docetaxel has a marginal objective activity in pancreatic cancer, it seems to have an important effect on tumor growth control, conferring a clinical benefit.

A phase II study of combination chemotherapy with gemcitabine, 5-fluorouracil, and cisplatin (GFP) for advanced pancreatic cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 14066-14066
Author(s):  
S. R. Kim ◽  
S. B. Choi ◽  
Y. J. Yuh
Keyword(s):  
Pancreatic Cancer ◽  
Combination Chemotherapy ◽  
Advanced Pancreatic Cancer ◽  
Phase Iii ◽  
Standard Regimen ◽  
Who Grade ◽  
Phase Iii Trial ◽  
Clinical Benefit Response ◽  
Grade 3 ◽  
Measurable Lesion

14066 Background: Gemcitabine has been the standard regimen for advanced pancreatic cancer, but the effect on the response rate and survival is still disappointing. 5-fluorouracil(5-FU) and cisplatin are synergistic with gemcitabine as well as with each other. This study is aimed to determine the efficacy and safety of combination chemotherapy with gemcitabine, 5-FU and cisplatin for advanced pancreatic cancer. Methods: Patients(pt) with recurred or advanced pancreatic cancer were entered into this study, who had histologically proven adenocarcinoma, no prior radiotherapy, measurable lesion (≥2cm), ECOG performance scale (PS) 0–2, age 18–70, adequate bone marrow, cardiac and renal function, ALT ≤ 3× normal, and total bilirubin ≤ 2mg/dL.The pt were treated every 3weeks with gemcitabine 800 mg/m2, at 10mg/m2/min on days 1 and 8, 5-FU 1g/m2/24 hour continuous infusion from day 1 through 3 for 72 hours (extended to 4 days later in 12 pt due to lack of toxicity), and cisplatin 60 mg/m2 on day 2, 24 hours after the start of gemcitabine. Concurrent chemo-radiotherapy with gemcitabine 250 mg/m2/week was given to the pt with response of stable disease or better after 4 cycles of chemotherapy, if PS ≤1 and age ≤ 65. Results: Characteristics of 25 eligible pt; 17 male/ 8 female, PS 0,1 in 20 pt, 2 in 4 pt, Stage III in 3 pt, IV in 22, age 40–69 (median 62). Five pt had prior 5-FU-based chemotherapy. A total of 109 cycles were given (median 4; 1–10 cycles/person). Response by WHO criteria: 3 PR (14.3%; 95% confidence interval: 0 - 29.6%), 11 SD (52.4%) and 7 PD in 21 assessable pt. The median time to progression was 230 days (48+-478+) and median survival was 322 days (70+-757+). WHO grade ≥3 toxicity: neutropenia 19.3% (/cycle), thrombocytopenia 28.4%, mucositis 1.8%, and nausea and vomiting 5.6%. The clinical benefit response and correlation of tumor response with CA-19–9 level will be detailed on presentation. Conclusions: The chemotherapy with gemcitabine, 5-FU and cisplatin for advanced pancreatic cancer is safe, active and may have better survival benefit than gemcitabine alone. Based on these results, a nationwide phase III trial comparing with gemcitabine alone has been started. No significant financial relationships to disclose.

Retrospective single center review of toxicity and efficacy of a modified FOLFIRINOX regimen in patients with locally advanced and metastatic pancreatic cancer.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 490-490 ◽  
Author(s):  
Bhargavi Pulluri ◽  
Joan Skelly ◽  
Maura Meredith Barry
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Medical Center ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Progression Free Survival ◽  
Median Number ◽  
Metastatic Pancreatic Cancer ◽  
Grade 3 ◽  
Number Of Treatment

490 Background: Conroy et al. (N Engl J Med 364:1817–1825, 2011) have shown significantly better overall survival with FOLFIRINOX compared to gemcitabine in metastatic pancreatic cancer patients (MPC). However, given the toxicity associated with FOLFIRINOX treatment, different institutions have adapted varying modifications to the original regimen. Methods: We performed a retrospective review of dose, toxicity, and efficacy of FOLFIRINOX in patients with unresectable locally advanced pancreatic cancer (LAPC) and MPC treated between Jan 2011 and Dec 2015 at University of Vermont Medical Center. Results: 43 patients were treated, of which 33 did not receive any prior treatment (6 LAPC, 27 MPC). 41 patients received dose attenuation with 1st cycle. Median relative dose of irinotecan, oxaliplatin and 5-FU were less than reported by Conroy (69 vs. 81%, 70 vs. 78% and 71 vs. 82%). Median number of treatment cycles 7.8 (range 1 to 41). Median progression free survival in our MPC cases compared to Conroy’s data was 5.7 vs. 6.4 months; overall survival at 6 and 12 months were 78 vs. 75.9% and 41 vs. 48.4% respectively. Grade ¾ toxicities were less, including neutropenia (p<0.001), fatigue (p =0.01) and neuropathy (p=0.04). One patient had grade 3 pneumonitis related to oxaliplatin. Conclusions: Our findings suggest that dose attenuation of 5-FU, irinotecan and oxaliplatin improve tolerability with fairly similar outcome as reported by Conroy et al. [Table: see text]

Phase I trial of thalidomide and capecitabine for treatment of metastatic colorectal cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 13552-13552
Author(s):  
M. J. Goldstein ◽  
J. C. Leighton ◽  
A. Chapman ◽  
A. Muskett ◽  
K. Sharan ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Phase I ◽  
Metastatic Colorectal Cancer ◽  
Single Agent ◽  
Median Number ◽  
Antitumor Effects ◽  
Disease Stabilization ◽  
Hand Foot Syndrome ◽  
Grade 3 ◽  
Ecog Ps

13552 Background: Survival of patients with metastatic colorectal cancer (CRC) has increased with the advent of new chemotherapeutic and biologic agents. Yet, there remains a need for more effective third- and fourth-line chemotherapy. Thalidomide (Thal) has angiogenic and immunomodulatory properties and antitumor effects have been consistently demonstrated in pts with multiple myeloma and occasionally in pts with advance solid tumors. Capecitabine (Cape) has demonstrated efficacy as a single agent and in combination therapy in pts with metastatic CRC. We conducted a phase I study of Thal/Cape in pts with refractory metastatic CRC previously treated with irinotecan, oxaliplatin and fluoropyrimidines. Methods: Pts with metastatic CRC who had received two or more prior chemotherapy regimens were eligible. Treatment consisted of Cape at 1500 mg/m2 po daily for 14 days every three weeks with dose levels increasing to 2500mg/m2; Thal dosing was initially 100 mg with escalations individually to 400 mg per day. Toxicity rates, response and overall survival were analyzed. Results: Twenty-five eligible pts were enrolled; median age= 58 (20–79); M/F=13/12; ECOG PS 0/1/2=11/12/2. The median number of Thal/Cape cycles administered was 3 (range 1–9). Treatment was well tolerated; grade 3–4 non-hematologic toxicities included somnolence/syncope (20%), fatigue (20%), constipation (10%), diarrhea (10%), infections (10%) and neuropathy, thrombosis, hypoglycemia, nausea/vomiting each occurred in 5% of pts; grade 3–4 hematological toxicities anemia (15%), neutropenia (5%), prolonged prothrombin time (15%), increased LFTs (10%). Grade 3–4 hand-foot syndrome occurred in 2 pt (8%). There were no radiographic responses, but 6 pts achieved a decline in CEA of 50% or greater and 6 pts achieved stable disease. Conclusion: The MTD is Cape 2500mg/m2 per day. The combination of Thal/Cape was well tolerated; the recommended dose is thal 200mg and cape 2000mg/m2. Despite the lack of radiographic responses, the rate and duration of disease stabilization observed in this heavily pretreated pt population suggest that this regimen may offer some benefit. [Table: see text]

A Critical Overview of Systematic Reviews of Chemotherapy for Advanced and Locally Advanced Pancreatic Cancer using both AMSTAR2 and ROBIS as Quality Assessment Tools

2020 ◽  
Vol 15 ◽  
Author(s):  
Amit Dang ◽  
Surendar Chidirala ◽  
Prashanth Veeranki ◽  
BN Vallish
Keyword(s):  
Pancreatic Cancer ◽  
High Risk ◽  
Systematic Reviews ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Risk Of Bias ◽  
Low Risk ◽  
Locally Advanced Pancreatic Cancer ◽  
Grade 3 ◽  
Critical Overview

Background: We performed a critical overview of published systematic reviews (SRs) of chemotherapy for advanced and locally advanced pancreatic cancer, and evaluated their quality using AMSTAR2 and ROBIS tools. Materials and Methods: PubMed and Cochrane Central Library were searched for SRs on 13th June 2020. SRs with metaanalysis which included only randomized controlled trials and that had assessed chemotherapy as one of the treatment arms were included. The outcome measures, which were looked into, were progression-free survival (PFS), overall survival (OS), and adverse events (AEs) of grade 3 or above. Two reviewers independently assessed all the SRs with both ROBIS and AMSTAR2. Results: Out of the 1,879 identified records, 26 SRs were included for the overview. Most SRs had concluded that gemcitabine-based combination regimes, prolonged OS and PFS, but increased the incidence of grade 3-4 toxicities, when compared to gemcitabine monotherapy, but survival benefits were not consistent when gemcitabine was combined with molecular targeted agents. As per ROBIS, 24/26 SRs had high risk of bias, with only 1/26 SR having low risk of bias. As per AMSTAR2, 25/26 SRs had critically low, and 1/26 SR had low, confidence in the results. The study which scored ‘low’ risk of bias in ROBIS scored ‘low confidence in results’ in AMSTAR2. The inter-rater reliability for scoring the overall confidence in the SRs with AMSTAR2 and the overall domain in ROBIS was substantial; ROBIS: kappa=0.785, SEM=0.207, p<0.001; AMSTAR2: kappa=0.649, SEM=0.323, p<0.001. Conclusion: Gemcitabine-based combination regimens can prolong OS and PFS but also worsen AEs when compared to gemcitabine monotherapy. The included SRs have an overall low methodological quality and high risk of bias as per AMSTAR2 and ROBIS respectively.

Sign in / Sign up

Export Citation Format

Share Document