Dose intensity of nab-paclitaxel and gemcitabine chemotherapy in metastatic pancreatic cancer.

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 251-251 ◽  
Author(s):  
Alexander Lim ◽  
Dae Won Kim ◽  
Kunhwa Kim ◽  
Richard D. Kim ◽  
Salvatore Michael Bottiglieri
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Combination Chemotherapy ◽  
Cox Regression ◽  
Dose Intensity ◽  
Hazard Ratio ◽  
Metastatic Pancreatic Cancer ◽  
Cancer Center ◽  
Cancer Management ◽  
All Cause Mortality

251 Background: Combination chemotherapy with nab-paclitaxel/gemcitabine is a standard of care option in metastatic pancreatic cancer management with increasing use due to an improvement in median overall survival of 1.8 months compared to gemcitabine alone. It is also used in practice in the second and third-line settings for patients that have progressed on fluorouracil based regimens. As the utility of this combination chemotherapy has grown, dose intensity (DI) in relation to survival outcome is an important measure for real world application. Methods: Fifty-six patients that were 18 years or older with metastatic pancreatic cancer treated with nab-paclitaxel/gemcitabine as first-line therapy from January 1, 2013 to December 31, 2014 at Moffitt Cancer Center were identified through medical records. The subjects were retrospectively reviewed, and demographic, treatment outcomes (survival and progression), and DI were collected. Overall survival was calculated with Kaplan Meier survival curves. Multi-Cox regression models estimated multivariable-adjusted hazard ratio with 95% confidence intervals. Results: There was no significant relationship between receiving a DI > 85% regimen in relation to independent variables of age > 65, sex, primary site, and known distant metastasis; however DI > 85% was significant for patients that received additional chemotherapy following nab-paclitaxel/gemcitabine (p = 0.044). The DI > 85% group compared to the < 85% group had a hazard ratio (HR) for all-cause mortality of 0.285 (0.106-0.764, p = 0.013). Six and 12-month survival were higher in the DI > 85% group (p = 0.009, p = 0.02 respectively). Conclusions: DI > 85% for nab-paclitaxel/gemcitabine compared to DI < 85% may have a lower all-cause mortality and higher 6 and 12-month survival.

Emerging concepts in combination chemotherapy for metastatic pancreatic cancer: A systematic review of randomized controlled trials.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 228-228
Author(s):  
Basile M. Njei ◽  
Ivo C. Ditah ◽  
Alexei Shimanovsky ◽  
Priscilla Owusu ◽  
John W Birk
Keyword(s):  
Quality Of Life ◽  
Pancreatic Cancer ◽  
Overall Survival ◽  
Combination Therapy ◽  
Adverse Events ◽  
Combination Chemotherapy ◽  
Metastatic Pancreatic Cancer ◽  
Controlled Trials ◽  
Randomized Controlled

228 Background: Even though gemcitabine monotherapy is commonly used as first-line treatment for metastatic pancreatic cancer, many novel treatment approaches have focused on combination chemotherapy. FOLFIRINOX, a combination of 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin, has recently been shown to improve survival compared to gemcitabine. However, it is unclear whether survival benefits are counterbalanced by a poor quality of life due to the adverse effects. The aim of this study was to review emerging strategies that enhance treatment of patients with metastatic pancreatic cancer. Methods: Two authors independently conducted a comprehensive search of the Cochrane library PUBMED, and published proceedings from major oncologic and gastrointestinal cancer meetings from January 1980 to July 2012. Only published randomized controlled trials were eligible for inclusion. Our primary outcome measures were: progression-free survival (PFS), overall survival (OS) and serious adverse events (grade 3 or 4). Results: Thirty-one studies involving 7,957 patients were included in the analysis. There was an overall statistically significant increase in OS (RR 1.10, 95% CI 1.03-1.30) and PFS (RR 1.27, 95% CI 1.14-1.46) for the gemcitabine-based combination therapy group versus the gemcitabine monotherapy group. Subgroup analysis showed that only patients with fluoropyrimidine and platinum containing regimens showed prolonged survival: RR 1.33, 95% CI 1.04-1.76 and RR 1.38, 95% CI 1.08-1.76, respectively. The most common severe adverse event (neutropenia) was found in 45% of patients treated with FOLFIRINOX. Conclusions: Overall, gemcitabine in combination with fluoropyrimidine or platinum containing regimens can improve overall survival in patients with metastatic pancreatic cancer compared to gemcitabine alone. Even though, FOLFIRINOX therapy is associated with better survival outcomes than gemcitabine, the prolonged survival comes at the cost of poorer quality of life due to a higher incidence of adverse events. More data is needed from studies involving novel combination therapy such as hedgehog pathway inhibitors and radio-immunotherapy.

Phase I/II trial of gemcitabine (Gem) plus irinotecan (CPT-11) for metastatic pancreatic cancer (MPC).

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 301-301
Author(s):  
Takuo Yamai ◽  
Tatsuya Ioka ◽  
Hironari Sueyoshi ◽  
Ryoji Takada ◽  
Nobuyasu Fukutake ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Phase I ◽  
Phase Ii ◽  
Combination Chemotherapy ◽  
Phase I Study ◽  
Progressive Disease ◽  
Metastatic Pancreatic Cancer ◽  
Refractory Ascites ◽  
Recommended Phase Ii Dose

301 Background: Treatment options for patients with metastatic pancreatic cancer are still limited. Recently, new strategies to prolong disease control are reported. We conducted phase I/II trial of GEM+CPT-11 combination chemotherapy for MPC to evaluate the effectiveness and safety. Methods: As phase I study, traditional 3 + 3 dose-escalation design was used to determine the maximum tolerated dose (MTD) and the recommended phase II dose. Four escalating dose levels of GEM/CPT-11 (800/60 mg/m2, 1000/60 mg/m2, 1000/80 mg/m2, and 1000/100 mg/m2) were studied. As results of this investigation, the recommended phase II dose was GEM 1000 mg/m2 and CPT-11 100 mg/m2, biweekly. Phase II eligibility included naïve MPC, PS0-2, Pathological diagnosis, no refractory ascites and pleural effusion, and adequate organ function. Primary endpoint was overall survival. Results: Eighteen patients were entered phase I study. The DLTs were anorexia, and nausea/vomiting. Severe neutropenia was rare. MTDs were determined GEM 1000 and CPT-11 100 mg/m2. After that, we investigated phase II trial in 40 patients. There were 6 partial response, 14 stable disease, 18 progressive disease and 2 in-evaluable. Response rate was 16%. The median overall survival was 7.5 months; progressive disease 4.0 months. Grade 3 to 4 toxicity included neutropenia (7%), anemia (7%), diarrhea (7%), ALT elevation (10%), pneumonitis(7%). There was no treatment-related death. Conclusions: This combination chemotherapy is not effective as first-line chemotherapy for metastatic pancreatic cancer. But this is safe and generally well tolerated. This chemotherapy could be effective of salvage chemotherapy with low toxicity after standard chemotherapy such as FOLFIRINOX.

Modified IPCW model: A method for adjusting for bias in the estimation of overall survival due to the use of second and third line therapies in locally advanced or metastatic pancreatic cancer patients.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15787-e15787
Author(s):  
N. E. Iznaga Escobar ◽  
Patricia Lorenzo Luaces ◽  
Lizet Sanchez Valdes ◽  
Carmen Valenzuela Silva ◽  
Tania Crombet Ramos ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Cancer Patients ◽  
Cox Regression ◽  
Locally Advanced ◽  
Secondary Analysis ◽  
Metastatic Pancreatic Cancer ◽  
Fixed Dose ◽  
Line Treatment ◽  
Newly Diagnosed

e15787 Background: Nimotuzumab, a unique and affinity differentiated anti-EGFR antibody had been used in combination with gemcitabine on the treatment of pancreatic cancer patients. The aim of the study was to evaluate overall survival. Methods: Patients with newly diagnosed, locally advanced or metastatic pancreatic cancer, KPS ≥ 70 %, 18-72 years old, with adequate renal and liver function were included. Pts received gemcitabine 1000 mg/m2and nimotuzumab or placebo fixed dose of 400 mg once a wk, for 3 wks, followed by a 1-wk rest (d1, 8, 15, q28) until disease progression or unacceptable toxicity. The primary endpoint was OS and secondary PFS, ORR, CBR, safety and QoL. For OS determination, a KM log-rank test was used and a modified IPCW with a cox regression as a secondary analysis. On this evaluation using a modified IPCW model, 41.7% of pts from treatment arm and 42.7% from control arm who received 2nd and 3rd line treatment were censored after progression, while pts that did not receive 2nd and 3rd line treatment were weighted to compensate for the bias created by censoring switchers to 2nd and 3rd line treatment. Results: 192 pancreatic cancer pts were recruited. Ninety-six pts (62 male and 34 female) with a median age of 67 years, range (31, 83) were randomized to treatment arm and 96 pts (57 male and 39 female) with a median age of 64 years, range (41, 82) were randomized to control arm. In the primary analysis, median OS [95% CI] in the treatment arm was 8.57 mo [5.93, 10.90] vs 6.03 mo [4.97, 7.60] in the control arm. The HR [95% CI], 0.83 [0.62, 1.12] and p = 0.23 and when a modified IPCW model as a secondary analysis was used to remove the effect of 2nd and 3rd line therapies, the median OS was statistically significant with a HR [95% CI], 0.81 [0.67, 0.98] and a p = 0.030. The median PFS [95% CI] was 4.43 mo [3.67, 6.00] in the treatment arm vs 3.47 mo [2.60, 4.03] in the control arm with a HR [95% CI] 0.68 [0.51, 0.92] and p = 0.012. Conclusions: A modified IPCW model had proven that addition of nimotuzumab to gemcitabine increases median overall survival of newly diagnosed chemotherapy-naïve locally advanced or metastatic pancreatic cancer patients. Clinical trial information: NCT00561990.

Correlation of neutrophil lymphocyte ratio, platelet lymphocyte ratio and rate of change of CA 19.9 in predicting outcome for metastatic pancreatic cancer.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 326-326
Author(s):  
Andrew Peter Dean ◽  
Dom Higgs ◽  
Adarsh Das ◽  
Madeline Rogers-Seeley ◽  
Sean Fennessy ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Cox Regression ◽  
Univariate Analysis ◽  
Rate Of Change ◽  
Cox Proportional Hazards Model ◽  
Metastatic Pancreatic Cancer ◽  
Lymphocyte Ratio ◽  
Daily Rate ◽  
Ca 19.9

326 Background: CA19.9, NLR and PLR have all been proposed as prognostic in pancreatic cancer. We analysed correlation between NLR, PLR and rate of change of CA19.9. Methods: A total of 63 metastatic pancreatic cancer patients were identified from our database and evaluated retrospectively for blood count, NLR, PLR and serial CA19.9 levels during treatment. Daily Rate of Change of CA19.9 levels were calculated for the first 90 days (DRC90) of the patient’s treatment. Kaplan-Meir curves, univariate and multivariate Cox-regression analyses were calculated to assess the effects of these 3 markers on overall survival. Results: In a univariate analysis, PLR > 240, NLR > 5 and DRC90 > 0.4% were all significantly associated with deceased overall survival. The Cox proportional hazards model showed that NLR < 5 (HR 0.475, 95% CI 0.259 to 0.873, P = 0.017), PLR < 240 (HR 0.444, 95% CI 0.229 to 0.861, P = 0.016), and a DRC90 < 0.4% (HR 0.294, 95% CI 0.102 to 0.851, P = 0.024) were independent predictors of good prognosis (22.6 months vs. 9.6 months, 22.3 months vs 12.4 months and 23.9 months vs. 9.3 months respectively). In multivariate analysis, only a DRC90 < 0.4% was independently associated with a longer survival (HR 0.239, 95% CI 0.076 to 0.752, P = 0.014). The formula (F) {PLR + (NLRxNLR) + (DRC90 x 100)} was predictive for survival, as patients with F > 190 (HR 3.295, 95% CI 1.232 to 8.807, P = 0.017), having a significantly lower survival rate than patients with F < 190 (25.1 months vs. 10.6 months, log-rank P = 0.009). Conclusions: These findings indicate the prognostic utility of the rate of CA 19.9 decline - measured as a standardised daily percentage change in value over 90 days. Our data validates daily rate of change of CA 19.9 over 90 days as an independent variable that correlates with prognosis, independent of PLR and NLR. We also identified a novel formula - PLR + (NLRxNLR) + (DRC90 x 100) - as being predictive for survival. We would like to increase the sample size to further validate our initial findings and investigate possible relationships in combining these variables for better prognostication in metastatic pancreatic cancer.

Correlation of HuR cytoplasmic expression in pancreatic cancer and overall patient survival when treated with gemcitabine in the adjuvant setting

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 11097-11097 ◽  
Author(s):  
J. Brody ◽  
A. Dasgupta ◽  
C. L. Costantino ◽  
E. Kennedy ◽  
C. J. Yeo ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Radiation Therapy ◽  
Median Overall Survival ◽  
Cox Regression ◽  
Treatment Strategies ◽  
Hazard Ratio ◽  
Metabolic Enzyme ◽  
Expression Levels ◽  
Risk Of Death

11097 Background:The Hu/ELAV mRNA binding protein HuR is normally localized to the nucleus and is activated upon stress. Previously, we observed that HuR expression is predominantly cytoplasmic in aggressive forms of pancreatic ductal adenocarcinomas (PDA). Additionally, we have shown that overexpression of HuR in pancreatic cancer cell lines renders them hypersensitive to gemcitabine (GEM). GEM is the standard first line therapy used against PDA. This study was designed to determine the relationship between endogenous HuR expression levels and patient outcome. Methods: We analyzed tissue from 29 resected PDA patients who did not receive neoadjuvant therapy. We determined the intensity of cytoplasmic HuR expression. All patients received adjuvant GEM, alone or in combination with radiation therapy or other chemotherapeutics. Correlation between HuR expression levels and overall survival was evaluated. Results: The median overall survival was 20.6 months, with 18 deaths observed. Median overall survival for low HuR expression was 15.3 months. Median overall survival for high HuR expression was not reached at a follow up of 40 months. A univariate Cox regression model gives a hazard ratio of low to high HuR of 3.36 (p=0.025) [95% CI 1.09–10.35]. Adjusting for age, sex, and radiation therapy in this patient group gives an adjusted hazard ratio of 5.04 (p = 0.03) [95% CI 1.15–22.02]. This indicates a 5-fold increase in risk of death in patients with low HuR levels compared to high HuR levels among patients receiving GEM. Conclusions: This is the first report of a correlation between levels of cytoplasmic HuR expression and overall survival in GEM treated patients. Together with our previously reported experimental data, HuR is regulating the key metabolic enzyme for GEM activation (deoxycytidine kinase). Therefore, HuR is a marker for therapeutic efficacy of GEM based regimens and is a candidate target for the optimization of GEM based treatment strategies. [Table: see text] No significant financial relationships to disclose.

scholarly journals Efficacy of Chemotherapy Integrated With Traditional Korean Medicine in Patients With Metastatic Pancreatic Cancer: A Single-Center Retrospective Study

2020 ◽  
Vol 19 ◽  
pp. 153473542098345
Author(s):  
Eun Hye Kim ◽  
Jee-Hyun Yoon ◽  
Sung Soo Yoon ◽  
Jee Young Lee ◽  
Seong Woo Yoon
Keyword(s):  
Pancreatic Cancer ◽  
Retrospective Study ◽  
Adverse Events ◽  
Cox Regression ◽  
Eastern Cooperative Oncology Group ◽  
Hazard Ratio ◽  
Metastatic Pancreatic Cancer ◽  
Traditional Korean Medicine ◽  
Korean Medicine ◽  
Cox Regression Analysis

Background: This retrospective study investigated the efficacy and safety of chemotherapy (CTX) integrated with Traditional Korean Medicine (TKM) in patients with metastatic pancreatic cancer, in a single Korean center. Methods: From January, 2014 to February, 2019, patients with metastatic pancreatic cancer who had received CTX were enrolled. Overall survival (OS), demographic characteristics, and adverse events were examined. Statistical analysis was utilized to evaluate the differences in characteristics and to compare the survival rates between the CTX group and CTX+TKM group. Kaplan-Meier curves were used to compare the differences in survival time. A Cox regression analysis was performed to determine the hazard ratio of the risk of mortality. Results: A total 37 participants were included and visited a TKM hospital 7.4 ± 8.3 months after being diagnosed with metastatic pancreatic cancer. The median age of the participants was 62 years; 26 patients (70.3%) had an Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2, and 23 patients (62.2 %) had first-line CTX failure. The median OS of all patients was 3.8 months (95% CI, 3.1-4.6). The CTX + TKM group showed longer survival (4.1 months; 95% CI, 2.4- .8) than the CTX group (2.4 months, 95% CI 0.2-4.6) but this was not statistically significant ( P = .217). Chemotherapy with TKM treatment for more than 30 days (CTX + TKM ≥ 30) significantly prolonged median OS (9.1 months; 95% CI, 3.6-14.5; P = .025) compared to chemotherapy alone. Cox hazard ratio analysis revealed that CTX + TKM ≥ 30 and prior chemotherapy were significantly independent prognostic factors for OS. The main herbs in the TKM treatment were Rhus verniciflua Stokes and Astragalus. Severe adverse events with respect to TKM treatment were not reported. Conclusions: TKM treatment integrated with chemotherapy may prolong OS in patients with metastatic pancreatic cancer compared to chemotherapy treatment alone. More rigorous prospective clinical trials are needed to confirm this result.

scholarly journals Randomized Phase III Study of Gemcitabine Plus S-1, S-1 Alone, or Gemcitabine Alone in Patients With Locally Advanced and Metastatic Pancreatic Cancer in Japan and Taiwan: GEST Study

2013 ◽  
Vol 31 (13) ◽  
pp. 1640-1648 ◽  
Author(s):  
Hideki Ueno ◽  
Tatsuya Ioka ◽  
Masafumi Ikeda ◽  
Shinichi Ohkawa ◽  
Hiroaki Yanagimoto ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Surface Area ◽  
Body Surface Area ◽  
Body Surface ◽  
Locally Advanced ◽  
Hazard Ratio ◽  
Phase Iii ◽  
Metastatic Pancreatic Cancer ◽  
Phase Iii Study

Purpose The present phase III study was designed to investigate the noninferiority of S-1 alone and superiority of gemcitabine plus S-1 compared with gemcitabine alone with respect to overall survival. Patients and Methods The participants were chemotherapy-naive patients with locally advanced or metastatic pancreatic cancer. Patients were randomly assigned to receive only gemcitabine (1,000 mg/m2 on days 1, 8, and 15 of a 28-day cycle), only S-1 (80, 100, or 120 mg/d according to body-surface area on days 1 through 28 of a 42-day cycle), or gemcitabine plus S-1 (gemcitabine 1,000 mg/m2 on days 1 and 8 plus S-1 60, 80, or 100 mg/d according to body-surface area on days 1 through 14 of a 21-day cycle). Results In the total of 834 enrolled patients, median overall survival was 8.8 months in the gemcitabine group, 9.7 months in the S-1 group, and 10.1 months in the gemcitabine plus S-1 group. The noninferiority of S-1 to gemcitabine was demonstrated (hazard ratio, 0.96; 97.5% CI, 0.78 to 1.18; P < .001 for noninferiority), whereas the superiority of gemcitabine plus S-1 was not (hazard ratio, 0.88; 97.5% CI, 0.71 to 1.08; P = .15). All treatments were generally well tolerated, although hematologic and GI toxicities were more severe in the gemcitabine plus S-1 group than in the gemcitabine group. Conclusion Monotherapy with S-1 demonstrated noninferiority to gemcitabine in overall survival with good tolerability and presents a convenient oral alternative for locally advanced and metastatic pancreatic cancer.

scholarly journals Overall survival in patients with metastatic pancreatic cancer after surgically primary tumor resected: a SEER-based nomogram analysis

2020 ◽  
Author(s):  
Maoen Pan ◽  
Yuanyuan Yang ◽  
Xiaoting Wu ◽  
Heguang Huang
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Prognostic Factors ◽  
Primary Tumor ◽  
Cox Regression ◽  
Predictive Accuracy ◽  
Tumor Resection ◽  
Training Group ◽  
Metastatic Pancreatic Cancer ◽  
Cox Regression Analysis

Abstract Background This study aimed to establish and validate a nomogram to predict overall survival in patients with metastatic pancreatic cancer (mPC) after surgically primary tumor resected. Methods All mPC patients who underwent primary tumor resection at SEER database between 2004 and 2016 were identified. We randomly assigned two-thirds of the patients to the training group and one third to the validation group. In the training group, the Kaplan–Meier survival analysis was used to analyze survival outcomes. A univariate and multivariate cox regression analysis was used to identify significant prognostic factors for establishing a nomogram. The predictive accuracy and discriminative ability were measured by the concordance index (C-index) and risk group stratification. Results A total of 742 patients were included for analysis. Four significant prognostic factors were obtained and included in the nomogram. The nomogram showed an acceptable discrimination ability (C- index:0.711) and good calibration and was further validated in the validation cohort (C- index: 0.727). The nomogram total points (NTP) had the potential to stratify patients into 2-risk groups with a median OS of 11 and 4.5 months (P < 0.001), respectively. Conclusions The nomogram can provide considerable accuracy individual prediction OS outcomes in patients with metastatic pancreatic cancer undergone primary tumor surgery and it can guide clinicians to make decisions in the clinical therapies.

HGCSG 1803: Single-arm phase II study evaluating efficacy of oxaliplatin, irinotecan and S-1 combination therapy (OX-IRIS) in metastatic pancreatic cancer as first-line treatment.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. TPS4668-TPS4668
Author(s):  
Shintaro Nakano ◽  
Yasuyuki Kawamoto ◽  
Satoshi Yuki ◽  
Kazuaki Harada ◽  
Susumu Sogabe ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Continuous Infusion ◽  
Phase Ii ◽  
Combination Chemotherapy ◽  
Phase Ii Study ◽  
Advanced Pancreatic Cancer ◽  
Dose Intensity ◽  
Progression Free Survival ◽  
New Combination ◽  
Metastatic Pancreatic Cancer

TPS4668 Background: Combination chemotherapy with oxaliplatin, irinotecan, fluorouracil and leucovorin (FOLFIRINOX) showed improved survival compared to gemcitabine monotherapy for patients with metastatic pancreatic cancer and has become the one of the standard regimens. Despite of its clinical benefit, FOLFIRNIOX needs continuous infusion of 5-FU for 46 hours, which impairs quality of life. In other gastrointestinal cancer, infuser pomp free regimens, in which oral 5-FU drug replace the continuous infusion of 5-FU, have developed as alternative regimen. Therefore, we planned to develop new combination chemotherapy with oxaliplatin, irinotecan and S-1 (OX-IRIS) for advanced pancreatic cancer. We previously conducted the phase Ⅰ study for assessing the safety and determining the recommended dose of OX-IRIS regimen. Methods: To evaluate efficacy and safety of OX-IRIS, HGCSG1803 study staeted as a multicenter, non-randomized, single arm, prospective, phase II study in December 2019. The patients with untreated metastatic or relapsed pancreatic cancer are eligible for this study. OX-IRIS is administered as follows; a 30-min intravenous infusion (IV) of antiemetic, a 2-h IV of oxaliplatin at 85 mg/m2, a 1.5-h IV of irinotecan at 150 mg/m2 on day 1 and day 15 of each 4-week cycle, and S-1 (40 mg/m2) was taken orally twice daily, from after dinner on day 1 to after breakfast on day 15, followed by a 14-day rest, and to be repeated every 2 weeks until disease progression, unacceptable toxicity, or patient refusal. The primary endpoint is response rate, and the secondary endpoints are overall survival, progression-free survival, safety, and dose intensity for each drug. A total of 40 cases are planned for registration from 18 institutions in Japan within 2.5 years. Clinical trial information: jRCTs011190008 .

Concurrent high-dose intensity-modulated radiotherapy and chemotherapy for unresectable locally advanced and metastatic pancreatic cancer: a pilot study

2021 ◽  
pp. 1-6
Author(s):  
Kenichi Matsumoto ◽  
Akihiko Miyamoto ◽  
Tomoya Kawase ◽  
Taro Murai ◽  
Yuta Shibamoto
Keyword(s):  
Pancreatic Cancer ◽  
Locally Advanced ◽  
Intensity Modulated Radiotherapy ◽  
Dose Intensity ◽  
Progression Free Survival ◽  
Concurrent Chemotherapy ◽  
Metastatic Pancreatic Cancer ◽  
High Dose ◽  
Chemotherapy Group ◽  
Intensity Modulated

Abstract Aim: To evaluate the efficacy of concurrent chemotherapy and high-dose (≥55 Gy) intensity-modulated radiotherapy (CCIMRT) in comparison with chemotherapy alone and intensity-modulated radiotherapy (IMRT) alone for unresectable locally advanced or metastatic pancreatic cancer. Methods: Forty-six patients with pancreatic cancer undergoing CCIMRT (n = 17), chemotherapy alone (n = 16) or IMRT alone (n = 13) were analysed. Overall survival (OS), locoregional progression-free survival (LRPFS) and gastrointestinal toxicities were evaluated. The median radiation dose was 60 Gy (range, 55–60) delivered in a median of 25 fractions (range, 24–30). Gemcitabine (GEM) alone, GEM + S-1, S-1 alone, FOLFIRINOX and GEM + nab-paclitaxel were used in CCIMRT and chemo-monotherapy. Results: The 1-year OS rate was 69% in the CCIMRT group, 27% in the chemotherapy group and 38% in the IMRT group (p = 0·12). The 1-year LRPFS rate was 73, 0 and 40% in the 3 groups, respectively (p = 0·012). Acute Grade ≥ 2 gastrointestinal toxicity (nausea, diarrhea) was observed in 12% (2/17) in the CCIMRT group, 25% (4/16) in the chemotherapy group and 7·7% (1/13) in the IMRT group (p = 0·38). Late Grade 3 gastrointestinal bleeding was observed in 6·3% (1/16) in the chemotherapy group. Conclusion: High-dose CCIMRT yielded acceptable toxicity and favorable OS and LRPFS.

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