A randomized phase II clinical trial of gemcitabine, oxaliplatin, erlotinib combination chemotherapy versus gemcitabine and erlotinib in previously untreated patients with locally advanced or metastatic pancreatic cancer.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 344-344 ◽  
Author(s):  
Sung Hee Lim ◽  
Jina Yun ◽  
Min-Young Lee ◽  
Han Jo Kim ◽  
Kyoung Ha Kim ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Response Rate ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Metastatic Pancreatic Cancer ◽  
Overall Response ◽  
Significant Difference ◽  
Common Grade ◽  
Secondary Endpoints ◽  
Grade 3

344 Background: Erlotinib is the only targeted agent in combination with gemcitabine showing significantly improved outcomes in pancreatic cancer. Although combining platinum agent with gemcitabine has not provided clear survival benefit over gemcitabine alone, gemcitabine plus platinum resulted in improved response rate and progression-free survival (PFS). We tried to evaluate whether the addition of oxaliplatin to gemcitabine/erlotinib confers a clinical benefit to patients with locally advanced or metastatic pancreatic cancer. Methods: Chemotherapy-naïve patients with locally advanced or metastatic pancreatic cancer were randomly assigned to receive GEMOX-T (gemcitabine 1000mg/m2 IV and oxaliplatin 50mg/m2 IV on day 1, 8 plus erlotinib 100mg daily, every 3weeks) or GT (gemcitabine 1000mg/m2 IV on day 1, 8 plus erlotinib 100mg daily, every 3weeks). The primary endpoint was overall response and secondary endpoints included PFS, overall survival (OS) and toxicity. Results: Between May 2013 and April 2016, 65 patients were randomly assigned to treatment group (33 in GEMOX-T arm, 32 in GT arm). The median age of all patients was 61 years (range, 41-76) and about 80% of patients had metastatic disease. The overall response rate was 18.2 % in GEMOX-T arm and 6.2% in GT arm ( P = 0.051). The disease control rate was significantly superior in GEMOX-T arm compared to GT arm (72.7% vs. 43.8%, P = 0.019), with 1 patient in GEMOX-T group continuing the treatment with stable disease. After a median follow up of 19.7 months, there was significant difference in PFS: the median PFS were 3.9 months for GEMOX-T arm and 1.4 months for GT arm (Hazard ratio: 0.58, 95% CI 0.35-0.96, P = 0.037). However, it did not translate to improvement of OS (median OS; 6.2 m for GEMOX-T arm, 5.1 m for GT arm, P = 0.118). The most common grade ≥ 3 hematologic adverse events were neutropenia (16.9%) and anemia (13.8%). Conclusions: The addition of oxaliplatin to 1st line gemcitabine/erlotinib regimen demonstrated higher response rate and significantly improved PFS in patients with locally advanced or metastatic pancreatic cancer.

scholarly journals Efficacy of Chemotherapy for Locally Advanced and Metastatic Pancreatic Cancer: A real life experience and outcome from a tertiary referral centre.

2021 ◽  
Vol 7 (2) ◽  
Author(s):  
Samia Yasmeen ◽  
Sabah Shaukat ◽  
Farah Arshad ◽  
Farhana Badar ◽  
Syed Ather Saeed Kazmi ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Response Rate ◽  
Chemotherapy Regimen ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Progression Free Survival ◽  
Metastatic Pancreatic Cancer ◽  
Free Survival ◽  
Significant Difference

Introduction: To report response rate, progression-free survival and overall survival in patients with advanced pancreatic cancer treated with different available chemotherapeutic regimens over ten years. Materials and Methods: This is a retrospective observational study. All patients with locally advanced and metastatic pancreatic cancer at Shaukat Khanum Memorial Cancer Hospital and Research Centre, Lahore, Pakistan, from January 2008 to December 2017 were studied. Data were collected from the hospital information system. The characteristics and outcomes of all the patients were analyzed. Progression-free survival and overall survival were also estimated. Kaplan Meier curves and Log-rank test were applied, and SPSS version 20 was used for data analysis. Results: Eighty-seven (87) subjects with a median age of 56 years (range 21-76) were included. Sixty-two (71%) subjects were male. The most common tumor location was the head of the pancreas in 46(53%) of all the subjects. Sixty-three (72%) subjects had elevated CA-19.9 values. About 47(54%) subjects had locally advanced pancreatic cancer (LAPC), and 40(46%) subjects had metastatic pancreatic cancer (MPC). Chemotherapy regimens used were FOLFIRINOX in 23(26%), gemcitabine-based 66(65%) and capecitabine-based in 8 (9%) of the subjects.  One (1%) subject had a complete response (CR), 12(14%) had a partial response (PR), 10 (11%) had stable disease, and 59(68%) of the subjects had progressive disease (PD). The objective response rate (ORR) was 15%, and the disease control rate (DCR) was 26%. In MPC, the ORR was 10%, DCR was 18%, and tumor progression was seen in 72% of the patients, while in LAPC, the ORR was 19.1, DCR 34% and tumor progression was documented in 64% of the patients, respectively. The FOLFIRNOX chemotherapy regimen had better ORR, DCR and lesser number of progressions as compared to Gemcitabine and Capecitabine based chemotherapy regimens. The Median PFS of the whole group was 32-weeks, and the median OS was 54-weeks. The PFS was significantly higher for LAPC (39 weeks) as compared to the MPC group (25 weeks) (p=0.028). There was no statistically significant difference between the OS of these 2 groups (p=0.451). In addition, PFS was significantly higher with FOLFIRINOX chemotherapy as compared to the other chemotherapy regimens. Regarding OS, there was no statistically significant difference among all chemotherapy regimen groups (p=0.267). Conclusion: Based on our results, FOLFIRINOX remained the most effective chemotherapy regimen despite the dose modifications and toxicities in all groups, indicating that modified FOLFIRINOX could be considered as a first-line regimen in south East Asian population.

scholarly journals Association between neutropenia and survival to nab-paclitaxel and gemcitabine in patients with metastatic pancreatic cancer

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Giandomenico Roviello ◽  
Monica Ramello ◽  
Martina Catalano ◽  
Alberto D’Angelo ◽  
Raffaele Conca ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Response Rate ◽  
Progression Free Survival ◽  
Metastatic Pancreatic Cancer ◽  
Common Side Effect ◽  
First Line ◽  
Free Survival ◽  
Grade 3 ◽  
Toxicity Criteria

Abstract Neutropenia is a common side effect associated with nab-paclitaxel gemcitabine (Nab-Gem) therapy. We retrospectively investigated the association between neutropenia induced by first-line Nab-Gem and survival in metastatic pancreatic carcinoma patients. Metastatic pancreatic patients treated with first-line Nab-Gem were included in this retrospective analysis. Neutropenia was categorized using the National Cancer Institute Common Toxicity Criteria scale. Outcome measures were overall survival (OS), progression-free survival (PFS) and response rate. 115 patients were analyzed. Median PFS was 7 months (95% CI 5–8) for patients with grade ≥ 3 neutropenia and 6 months (95% CI 5–6) for patients with grade < 3 neutropenia [p = 0.08; hazard ratio (HR 0.68)]. Median OS was 13 months (95% CI 10–18) for patients with grade ≥ 3 neutropenia and 10 months (95% CI 8–13) for patients with grade < 3 neutropenia (p = 0.04; HR 0.44). In multivariate analysis, the occurrence of grade ≥ 3 neutropenia showed a statistically significant association with OS (HR 0.62; 95% CI 0.09–0.86; p = 0.05). Nab-Gem-induced neutropenia is associated with longer survival in metastatic pancreatic cancer patients.

Safety and efficacy of modified FOLFIRINOX in pancreatic cancer: A retrospective experience.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e14614-e14614 ◽  
Author(s):  
Hemchandra Mahaseth ◽  
John S. Kauh ◽  
Edith Brutcher ◽  
Natalyn Nicole Hawk ◽  
Sungjin Kim ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Performance Status ◽  
Single Agent ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Metastatic Pancreatic Cancer ◽  
Clinical Activity ◽  
Ecog Performance Status ◽  
Emory University ◽  
Grade 3

e14614 Background: Conroy et al reported a significant improvement in overall survival of patients with metastatic pancreatic cancer treated with FOLFIRINOX compared to single agent gemcitabine. The regimen was associated with significant grade 3/ 4 toxicities, such as myelosuppression(46%), fatigue(24%), vomiting(15%) and diarrhea (13%). In order to improve the toxicity profile, we have modified FOLFIRINOX (mFOLFIRINOX) regimen by removing the bolus 5-FU and adding the routine use of growth factor prophylaxis. We present our experience with mFOLFIRINOX in patients with locally advanced or metastatic pancreatic cancer. Methods: After obtaining IRB approval, patients with a diagnosis of pancreatic cancer were identified from the Emory University tumor registry. Twenty eight patients who received at least one dose of mFOLFIRINOX (5-FU 2400 mg/m2 CIVI over 46 hours, leucovorin 400 mg/m2, oxaliplatin 85 mg/m2, irinotecan 180 mg/m2 and pegfilgrastim 6 mg every two weeks ) were selected and their charts were retrospectively reviewed for safety, response, and survival. Results: Of 28 patients, 14 (50%) were male, 18 (64%) white, 8 (29%) black and other 2(7%). Median age was 63 (50-75) and ECOG performance status 0-1. Nineteen (68%) patients had primary tumor located in head of pancreas. Eight patients (29%) experienced grade 3/4 toxicities, i.e., nausea/vomiting (11%), diarrhea (11%), fatigue (11%), neuropathy (4%), neutropenia (4%), thrombocytopenia(4%), and sepsis not-related to neutropenia (4%). No grade 3/4 anemia or febrile neutropenia was noted. mFOLFIRINOX controlled the disease in 20 patients (71%) with 2 CR, 4 PR and 14 SD. With a median follow up of 5.5 months, median overall or progression free survival is not reached. Two patients have died and six patients have progressed. Conclusions: Modified FOLFIRINOX is well tolerated in this US population. The clinical activity appears very promising with majority of patients being free of progression.

Patterns of failure in a phase II trial of neoadjuvant chemotherapy and stereotactic body radiation therapy (SBRT) for resectable and borderline resectable (BLR) pancreatic cancer.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 482-482 ◽  
Author(s):  
Jordan Kharofa ◽  
Michelle Lynn Mierzwa ◽  
Olugbenga Olanrele Olowokure ◽  
Jeffrey J. Sussman ◽  
Tahir Latif ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Cumulative Incidence ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Local Failure ◽  
Borderline Resectable ◽  
Target Volumes ◽  
Secondary Endpoints ◽  
Optimal Target ◽  
Grade 3

482 Background: There is emerging interest in the role of SBRT in locally advanced pancreas cancer, however little prospective data exists examining the safety, efficacy, and optimal target volumes for SBRT in the neoadjuvant setting for resectable or BLR pancreatic cancer. Methods: Eighteen patients were enrolled from 11/2014-6/2017. SBRT was delivered to the tumor and abutting vessel with fiducials/compression and a 3 mm PTV margin to 33 Gy (6.6 Gyx5fxn) with an optional elective PTV to 25 Gy (5 Gyx5fxn) customized to the nodal space and mesenteric vessels. Patients without progression underwent surgery 4-6 weeks following SBRT. The primary endpoint is ≥ Grade 3 acute and late GI toxicity. Secondary endpoints included overall survival (OS), progression-free survival (PFS),and cumulative incidence of local failure (LF). LF is defined as recurrence within conventional RT volumes from the time of resection to local failure or last CT with no progression. Local failures were fused to planning CTs for dose quantification. Results: Thirteen patients had BLR tumors due to arterial abutment (n = 7) or SMV encasement (n = 8); 3 patients had resectable tumors. All patients received 4 months of gemcitabine/nab-paclitaxel (n = 13) or FOLFIRNOX (n = 5) prior to SBRT. There were no ≥ Grade 3 acute or late GI events. Metastases were noted in 6 patients (33%) at restaging or surgery. Surgery was performed in 12 patients (67%) with 11 (92%) R0 resections. Median OS and PFS are 21 months and 11 months, respectively. Progression occurred in 67% (8/12) of resected patients with first site of failure as distant (n = 3, 38%), local only (n = 4, 50%), and local and distant (n = 1,13%). The cumulative incidence of LF at 12 months from resection was 50%. All LF were outside to the PTV33 with median D90 of 11.5 Gy (4-25 Gy), V25 Gy of 51% (0-90%), and V33 Gy of 45% (0-52%). Conclusions: SBRT as a component of neoadjuvant therapy was well tolerated. However, local failures were predominantly observed outside the PTV33 volume within conventional RT volumes. Therefore, the durability of local control after SBRT in the neoadjuvant setting relative to chemoradiation merits close examination. Clinical trial information: NCT02208024.

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]

Irinotecan Plus Gemcitabine Results in No Survival Advantage Compared With Gemcitabine Monotherapy in Patients With Locally Advanced or Metastatic Pancreatic Cancer Despite Increased Tumor Response Rate

2004 ◽  
Vol 22 (18) ◽  
pp. 3776-3783 ◽  
Author(s):  
Caio M. Rocha Lima ◽  
Mark R. Green ◽  
Robert Rotche ◽  
Wilson H. Miller ◽  
G. Mark Jeffrey ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Tumor Progression ◽  
Tumor Response ◽  
Response Rate ◽  
Locally Advanced ◽  
Phase Iii ◽  
Metastatic Pancreatic Cancer ◽  
Tumor Response Rate ◽  
Grade 3

Purpose This phase III, randomized, open-label, multicenter study compared the overall survival associated with irinotecan plus gemcitabine (IRINOGEM) versus gemcitabine monotherapy (GEM) in patients with chemotherapy-naive, locally advanced or metastatic pancreatic cancer. Patients and Methods IRINOGEM patients received starting doses of gemcitabine 1,000 mg/m2 and irinotecan 100 mg/m2 given weekly for 2 weeks every 3-week cycle. GEM patients received gemcitabine 1,000 mg/m2 weekly for 7 of 8 weeks (induction) and then weekly for 3 of 4 weeks. The primary end point of the trial was survival. Secondary end points included tumor response, time to tumor progression (TTP), changes in CA 19-9, and safety. Results In each arm, 180 randomly assigned patients comprised the intent-to-treat population evaluated for efficacy; 173 IRINOGEM and 169 GEM patients were treated. Median survival times were 6.3 months for IRINOGEM (95% CI, 4.7 to 7.5 months) and 6.6 months for GEM (95% CI, 5.2 to 7.8 months; log-rank P = .789). Tumor response rates were 16.1% (95% CI, 11.1% to 22.3%) for IRINOGEM and 4.4% (95% CI, 1.9% to 8.6%) for GEM (χ2 P < .001). Median TTP was 3.5 months for IRINOGEM versus 3.0 months for GEM (log-rank P = .352). However, subset analyses in patients with locally advanced disease suggested a TTP advantage with IRINOGEM versus GEM (median, 7.7 v 3.9 months). CA 19-9 progression was positively correlated with tumor progression. The incidence of grade 3 diarrhea was higher in the IRINOGEM group but grade 3 to 4 hematologic toxicities and quality-of-life outcomes were similar. Conclusion IRINOGEM safely improved the tumor response rate compared with GEM but did not alter overall survival.

Necuparanib combined with nab-paclitaxel + gemcitabine in patients with metastatic pancreatic cancer: Phase 2 results.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 370-370 ◽  
Author(s):  
Eileen Mary O'Reilly ◽  
Devalingam Mahalingam ◽  
James M. Roach ◽  
Paul Justin Miller ◽  
Molly E. Rosano ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Phase 1 ◽  
Progression Free Survival ◽  
Response Rates ◽  
Complete Response ◽  
Metastatic Pancreatic Cancer ◽  
Phase 2 ◽  
Target Number ◽  
Common Grade ◽  
Grade 3

370 Background: The Phase 1 portion of a Phase 1/2 trial of Necuparanib (“Necu”) combined with nab-paclitaxel (nabP) + gemcitabine (gem) in patients with metastatic pancreatic cancer (ClinicalTrials.gov Identifier NCT01621243) showed acceptable safety and tolerability and encouraging signals of activity and established a dose for the randomized, placebo (PBO)-controlled Phase 2 portion. Methods: In Phase 2, patients received daily s.c. injections of either 5 mg/kg Necu daily or PBO, combined with i.v. 125 mg/m2 nabP and 1000 mg/m2 gem (Days 1, 8, 15 of each 28-day cycle). The primary endpoint was overall survival (OS); other endpoints included progression-free survival (PFS), response rates, safety, and CA19.9 levels. An interim futility analysis was conducted in July 2016 once 57 deaths (50% of the target number of 114 events required for trial completion) had occurred. Results: The analysis was conducted on data from 120 randomized patients (62 Necu, 58 PBO). The Z-score for futility was -0.42 (prespecified boundary of -0.148 was crossed as actual score was lower). Median OS was Necu = 10.71 and PBO = 9.99 months; hazard ratio (HR) = 1.12 (favoring PBO); OS curves were intertwined. PFS was Necu = 5.52 and PBO = 6.93 months; HR = 0.97. RECIST response rates were comparable between arms: complete response, Necu = 0%, PBO = 3%; partial response, Necu = 26%, PBO = 26%; stable disease, Necu = 31%, PBO = 34%; disease control rate, Necu = 56%, PBO = 64%. The most common Grade 3+ adverse events (AEs) were neutropenia (Necu = 33%, PBO = 33%), thrombocytopenia (Necu = 27%, PBO = 5%), and anemia (Necu = 22%, PBO = 11%). There were lower rate of serious AEs with Necu (48%) vs. PBO (60%). Modest increases in APTT, AST, and ALT were noted following Necu relative to PBO. 23% of Necu and 5% of PBO patients were IgG positive with an anti-heparin/PF4 antibody titer of ≥ 0.4 at any time. There were no treatment differences for decreases in CA19.9. Conclusions: No new safety signals were observed and the toxicity profile was considered manageable; however, Necu in combination with nabP and gem did not show a sufficient level of efficacy in metastatic pancreatic cancer to warrant continued enrollment. Clinical trial information: NCT01621243.

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.

Gemcitabine Plus Nab-Paclitaxel as Second-Line Chemotherapy following FOLFIRINOX in Patients with Unresectable Pancreatic Cancer: A Single-Institution, Retrospective Analysis

Chemotherapy ◽  
2021 ◽  
pp. 1-7
Author(s):  
Kotone Hayuka ◽  
Hiroyuki Okuyama ◽  
Akitsu Murakami ◽  
Yoshihiro Okita ◽  
Takamasa Nishiuchi ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Adverse Events ◽  
Advanced Pancreatic Cancer ◽  
Progression Free Survival ◽  
Unresectable Pancreatic Cancer ◽  
Line Treatment ◽  
Second Line ◽  
Free Survival ◽  
Common Grade ◽  
Grade 3

<b><i>Introduction:</i></b> Patients with advanced pancreatic cancer have a poor prognosis. FOLFIRINOX (FFX) and gemcitabine plus nab-paclitaxel (GnP) have been established as first-line treatment, but they have not been confirmed as second-line treatment after FFX. The aim of this study was to evaluate the safety and efficacy of GnP as second-line therapy after FFX in patients with unresectable pancreatic cancer. <b><i>Methods:</i></b> Twenty-five patients with unresectable pancreatic cancer were enrolled. The patients were treated with GnP after FFX between September 2015 and September 2019. Tumor response, progression-free survival (PFS), overall survival (OS), and incidence of adverse events were evaluated. <b><i>Results:</i></b> The response rate, disease control rate, median PFS, and median OS were 12%, 96%, 5.3 months, and 15.6 months, respectively. The common grade 3 or 4 adverse events were neutropenia (76%) and anemia (16%). <b><i>Conclusions:</i></b> GnP after FOLFIRINOX is expected to be one of the second-line recommendations for patients with unresectable pancreatic cancer.

Randomized Phase II Trial of First-Line Trastuzumab Plus Docetaxel and Capecitabine Compared With Trastuzumab Plus Docetaxel inHER2-Positive Metastatic Breast Cancer

2010 ◽  
Vol 28 (6) ◽  
pp. 976-983 ◽  
Author(s):  
Andrew M. Wardley ◽  
Xavier Pivot ◽  
Flavia Morales-Vasquez ◽  
Luis M. Zetina ◽  
Maria de Fátima Dias Gaui ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Response Rate ◽  
Performance Status ◽  
Locally Advanced ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
First Line ◽  
Her2 Positive ◽  
Grade 3

PurposeTo evaluate trastuzumab (H) and docetaxel (T) with or without capecitabine (X) as first-line combination therapy for human epidermal growth factor receptor 2 (HER2) -positive advanced breast cancer.Patients and MethodsPatients with HER2-positive locally advanced or metastatic breast cancer were randomly assigned to H (8 mg/kg loading; 6 mg/kg every 3 weeks) plus T (75 mg/m2in HTX arm, 100 mg/m2in HT arm, every 3 weeks) with or without X (950 mg/m2twice per day on days 1 to 14 every 3 weeks). The primary end point was overall response rate (ORR).ResultsIn 222 patients, median follow-up was approximately 24 months. ORR was high with both regimens (70.5% with HTX; 72.7% with HT; P = .717); complete response rate was 23.2% with HTX compared with 16.4% with HT. HTX demonstrated significantly longer progression-free survival: median 17.9 months compared with 12.8 months with HT (hazard ratio, 0.72; P = .045), which translates to a gain of around 5 months. Two-year survival probability was 75% with HTX compared with 66% with HT. Febrile neutropenia (27% v 15%) and grade 3/4 neutropenia (77% v 54%) incidences were higher with HT than HTX. Treatment-related grade 3 hand-foot syndrome (17% v < 1%) and grade 3/4 diarrhea (11% v 4%) occurred more commonly with HTX than HT. One case of congestive heart failure occurred in each arm.ConclusionHTX is an effective and feasible first-line therapy for HER2-positive locally advanced or metastatic breast cancer, although it should be reserved for patients with good performance status who are not receiving long-term steroids.

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