FOLFIRI regimen as second-/third-line chemotherapy in patients with advanced pancreatic adenocarcinoma refractory to gemcitabine and platinum salts: A retrospective series of 70 patients.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 272-272
Author(s):  
C. Neuzillet ◽  
O. Hentic ◽  
B. Rousseau ◽  
V. Rebours ◽  
L. Bengrine-Lefèvre ◽  
...  
Keyword(s):  
Pancreatic Adenocarcinoma ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Progression Free Survival ◽  
Tumor Control ◽  
First Line ◽  
Dose Adaptation ◽  
Grade 3 ◽  
Advanced Pancreatic Adenocarcinoma ◽  
Line Chemotherapy

272 Background: Gemcitabine-based regimen is a standard of first-line chemotherapy in patients with advanced pancreatic adenocarcinoma (PAC) and 5-FU/oxaliplatin combination is an option for second line (Oettle, 2009). Some data suggest a potential efficacy of 5-FU/irinotecan regimen (FOLFIRI) as first-line treatment (Taïeb, 2007)or in patients with gemcitabine/platinum-refractory advanced PAC (Yoo, 2009; Gebbia, 2010). Methods: All consecutive patients with unresectable advanced PAC (01-2005/05-2010) and OMS≤2 received FOLFIRI-1 (irinotecan 180 mg/m2 D1, n=60) or FOLFIRI-3 regimen (irinotecan 100 mg/m2 D1/D3 n=10) after failure of gemcitabine- and platinum-based chemotherapies as a systematic policy in two institutions. Following data were analyzed: tumor response, progression free survival (PFS), overall survival rate (OS), and grade 3-4 toxicities. Results: Seventy patients were studied. Median age was 60 years (range: 24-81); 37 (52.9%) were male; 30 (42.9%) were PS 0, 27 were PS 1 and 13 were PS 2. Cancer was locally advanced in 15.7% and metastatic in 84.3% of patients. Before FOLFIRI regimen, patients received 1 line (n=24, 34.3%), 2 lines (n=40, 57.1%) or ≥ 3 lines (n=6, 8.8%) chemotherapy. PFS with previous line was less than 3 months in most patients. Tumor control was achieved in 31 (44.3%) patients (partial response: 5, stable disease: 26). PFS was 17% at 12 months and 3% at 24 months. Median PFS was 23 weeks (range: 2-147). OS was 24% at 12 months and 9% at 24 months. Median OS was 24 weeks (range: 2-147). From the initial diagnosis, 1-year and 2-year survivals were 79% and 32%. Dose adaptation was required in 21 (30.0%) patients. Eighteen (25.7%) patients had grade 3-4 toxicities, mainly hematologic (n=13) or digestive (n=6). Febrile neutropenia occurred in 3 patients without death. Conclusions: FOLFIRI regimen after failure of gemcitabine- and platinum-based regimens for advanced PAC in our study had an acceptable toxicity and a surprising efficacy in patients OMS 0-2. These results suggest that FOLFIRI regimen should be further tested as first-line chemotherapy in patients with advanced pancreatic cancer. No significant financial relationships to disclose.

PANOVA: A pilot study of TTFields concomitant with gemcitabine for front-line therapy in patients with advanced pancreatic adenocarcinoma.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 269-269 ◽  
Author(s):  
Fernando Rivera ◽  
Javier Gallego ◽  
Carmen Guillen ◽  
Manuel Benavides ◽  
Jose A. Lopez-Martin ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Pancreatic Adenocarcinoma ◽  
Electric Fields ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Progression Free Survival ◽  
Grade 3 ◽  
Advanced Pancreatic Adenocarcinoma

269 Background: TTFields are alternating electric fields delivered to the region of the tumor by means of non-invasive transducer arrays. TTFields interfere with mitotic spindle formation, thus having an anti-mitotic activity. In pancreatic cancer, TTFields decreased proliferation and clonogenic potential in vitro, and reduced tumor volume in vivo. The PANOVA trial was designed to test TTFields, combined with chemotherapy, in pancreatic cancer. Methods: Twenty patients with advanced pancreatic adenocarcinoma were enrolled in a prospective, single arm study of TTFields at 150 kHz, concomitant with standard weekly gemcitabine. All patients had histologically-confirmed unresectable tumors, with an ECOG performance score of 0-1 and no prior chemotherapy or radiation therapy. The primary endpoint was incidence and severity of treatment emergent adverse events (AEs). Secondary endpoints included progression free survival (PFS), PFS rate at 6 months, overall survival (OS) and response rate. Results: The median age was 73 (range – 49-81) and 60% of the patients were females. Most patients (80%) had an ECOG score of 1. Twelve patients (60%) had distant metastases, while the others had locally advanced disease. Median compliance with TTFields was 78% (14 hours/day), with median duration of 5 months. Fourteen patients (70%) had serious (grade 3-5) AEs during the study period. Six patients (30%) had hematological, 45% gastrointestinal and 15% pulmonary AEs. Ten patients (50%) had treatment-related skin toxicity, of which only 2 were grade 3, both resolved with appropriate treatment. No TTFields-related serious AEs were reported. The median PFS was 8.3 months (95% CI 4.3, 10.3). PFS rate at 6 months was 56%. Of the evaluable tumors, 30% had partial response and another 30% stable disease. The median OS was 14.9 months and 1-year survival rate was 55%. Conclusions: TTFields concomitant to gemcitabine are tolerable and safe for advanced pancreatic cancer patients. The efficacy results are promising and support further research in this indication. An extension of the PANOVA protocol, including 20 additional patients who receive gemcitabine, nab-paclitaxel and TTFields is ongoing. Clinical trial information: NCT01971281.

scholarly journals Comparison of FOLFIRINOX, Gemcitabine Plus Nab-Paclitaxel, and Chemoradiotherapy as First-Line Treatments for Locally Advanced Pancreatic Cancer

2021 ◽  
Author(s):  
Shintaro Nakano ◽  
Yoshito Komatsu ◽  
Yasuyuki Kawamoto ◽  
Rika Saito ◽  
Ken Ito ◽  
...  
Keyword(s):  
Overall Survival ◽  
Pancreatic Adenocarcinoma ◽  
Locally Advanced ◽  
Survival Rates ◽  
Advanced Pancreatic Cancer ◽  
Progression Free Survival ◽  
First Line ◽  
Significant Difference ◽  
Locally Advanced Pancreatic Adenocarcinoma ◽  
Advanced Pancreatic Adenocarcinoma

Abstract Background: Currently, it is unclear whether chemotherapy or chemoradiotherapy (CRT) is the optimal first-line treatment for patients with locally advanced pancreatic adenocarcinoma. In this study, we compared the efficacy and safety of FOLFIRINOX (FFX), gemcitabine plus nab-paclitaxel (GnP), and CRT as first-line treatments for locally advanced pancreatic adenocarcinoma. Methods: We evaluated patients receiving FFX, GnP, or CRT, and assessed treatment efficacy in terms of overall survival and progression-free survival. Safety was evaluated using the Common Toxicity Criteria for Adverse Events (version 4.0). Results: Fifty-five patients were included in the analysis (10 for FFX, 25 for GnP, and 20 for CRT). The median overall survival was 7.1, 16.9, and 20.0 months in the FFX, GnP, and CRT groups, respectively. There was no significant difference in overall survival between the FFX and GnP groups (HR: 0.503, 95% CI: 0.205–1.238, p = 0.135), FFX and CRT groups (HR: 0.518, 95% CI: 0.213–1.256, p = 0.136), or GnP and CRT groups (HR: 0.993, 95% CI: 0.451–2.188, p = 0.987). The 1-year survival rates were 40%, 64%, and 60%, whereas the 2-year survival rates were 0%, 16%, and 35% in the FFX, GnP, and CRT groups, respectively. Conclusions: Both chemotherapy and CRT were effective and well tolerated. Thus, the combination of intensive chemotherapy and radiotherapy may be a beneficial treatment strategy.

scholarly journals Modified FOLFIRINOX versus gemcitabine plus oxaliplatin as first-line chemotherapy for patients with locally advanced or metastatic cholangiocarcinoma: a retrospective comparative study

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Lu Zou ◽  
Xuechuan Li ◽  
Xiangsong Wu ◽  
Jiujie Cui ◽  
Xuya Cui ◽  
...  
Keyword(s):  
Locally Advanced ◽  
Group Versus ◽  
Progression Free Survival ◽  
Severe Toxicity ◽  
First Line ◽  
School Of Medicine ◽  
Grade 3 ◽  
Retrospective Comparative Study ◽  
Registration Date ◽  
Line Chemotherapy

Abstract Background Gemcitabine plus platinum as the first-line chemotherapy for cholangiocarcinoma (CCA) has limited efficacy. The aim of this study was to evaluate the effectiveness of modified FOLFIRINOX (mFOLFIRINOX) compared to that of gemcitabine plus oxaliplatin (Gemox) for patients with locally advanced or metastatic CCA. Methods From January 2016 to December 2019, consecutive patients who were diagnosed with locally advanced or metastatic CCA were treated with either mFOLFIRINOX or Gemox as a first-line chemotherapy. The main endpoint was Progression free survival (PFS). The second endpoints were Overall survival (OS), Disease control rate (DCR) and incidence of severe toxicity (grade 3–4). Tumors were evaluated at baseline and thence every 4–6 weeks. The study was designed and carried out in accordance with the principles of the declaration of Helsinki, approved by the Ethics Committee of Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine (XHEC-D-2020-154) and registered with ClinicalTrials.gov, number NCT04305288 (registration date: 12/03/2020). Results Of 49 patients in this study, 27 were in the FOLFIRINOX regimen group and 22 in the Gemox regimen group. There were no significant differences between groups in baseline characteristics. The DCR was 77.8% in the mFOLFIRINOX group and 63.5% in the Gemox group. The corresponding median PFS was 9.9 months (95% confidence interval [CI], 7.3–12.4) in the mFOLFIRINOX group versus 6.4 months (95% CI,3.6–9.2, p = 0.040) in the Gemox group. The corresponding median OS was 15.7 months (95% CI, 12.5–19.0) versus 12.0 months (95% CI, 9.3–14.8, p = 0.099). Significantly more grade 3–4 vomiting occurred in the mFOLFIRINOX than the Gemox groups (7 (25.9%) vs 1 (4.5%), p = 0.044). Conclusions First-line mFOLFIRINOX offered more promising results in patients with advanced or metastatic CCA.

scholarly journals FOLFIRINOX after first-line gemcitabine-based chemotherapy in advanced pancreatic cancer: a retrospective comparison with FOLFOX and FOLFIRI schedules

2020 ◽  
Vol 12 ◽  
pp. 175883592094797
Author(s):  
Francesca Foschini ◽  
Fabiana Napolitano ◽  
Alberto Servetto ◽  
Roberta Marciano ◽  
Eleonora Mozzillo ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Progression Free Survival ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Optimal Sequence ◽  
Line Chemotherapy

Background: Pancreatic adenocarcinoma is the fourth leading cause of cancer-related death. In cases with metastasis, the combination of 5-fluorouracil, irinotecan, and oxaliplatin (FOLFIRINOX) or gemcitabine-based chemotherapy regimens are considered the standard of care. However, the optimal sequence of these regimens is unclear. Methods: This retrospective study initially evaluated 186 patients with locally advanced/metastatic pancreatic cancer at three Italian institutions between February 2013 and October 2019. All patients had progressed after receiving gemcitabine-based first-line chemotherapy and were subsequently offered second-line FOLFIRINOX, FOLFOX-6, or FOLFIRI treatment. This study evaluated progression-free survival (PFS), overall survival from the start of second-line treatment (OS2), overall survival from the start of first-line treatment (OS1), and safety outcomes. Results: A total of 77 patients received ⩾4 cycles of second-line chemotherapy and were considered eligible: 15 patients received FOLFIRINOX, 32 patients received FOLFOX-6, and 30 patients received FOLFIRI. The FOLFIRINOX group had median PFS of 26.29 weeks and median OS2 of 47.86 weeks, while the FOLFIRI group had median PFS of 10.57 weeks and median OS2 of 25.00 weeks ( p = 0.038). No significant differences were observed between the FOLFIRINOX and FOLFOX-6 groups in terms of PFS (26.29 weeks versus 23.07 weeks) or OS2 (47.86 weeks versus 42.00 weeks). The most common grade 3–4 toxicities were anemia, neutropenia, and thrombocytopenia, which occurred more frequently in the FOLFIRINOX and FOLFOX-6 groups. Conclusion: Relative to the FOLFIRI regimen, the FOLFIRINOX regimen had a favorable toxicity profile and better survival outcomes. No significant differences were observed relative to the FOLFOX-6 regimen.

Gemcitabine and S-1 as first-line chemotherapy in patients with metastatic or advanced pancreatic cancer.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 492-492 ◽  
Author(s):  
Weijia Fang ◽  
Peng Zhao ◽  
Yi Zheng ◽  
Weiqin Jiang
Keyword(s):  
Pancreatic Cancer ◽  
Advanced Pancreatic Cancer ◽  
Progression Free Survival ◽  
Chemotherapeutic Agents ◽  
Chinese Patients ◽  
Hematological Toxicity ◽  
Survival Times ◽  
First Line ◽  
Grade 3 ◽  
Line Chemotherapy

492 Background: Gemcitabine and S-1 are both effective antitumor chemotherapeutic agents for pancreatic cancer. We evaluate the efficacy and safety of the combination of gemcitabine (GEM) and S-1 (GS) as first-line chemotherapy in Chinese patients with metastatic or advanced pancreatic cancer. Methods: Patients with previously untreated metastatic or advanced pancreatic cancer who had measurable lesion(s) were enrolled. Gemcitabine was administered intravenously at a dose of 1,000 mg/m (2) during 30 min on days 1 and 8 and oral S-1 was given twice daily (BSA < 1.25 m(2), 80 mg/day; 1.25 ≤ BSA < 1.50 m(2), 100 mg/day; 1.50 m(2) ≤ BSA, 120 mg/day) on days 1-14 followed by a drug-free interval of 1 week every 21-day cycle. Results: Twenty-five patients were enrolled between 2012 and 2014. The assessed overall response rate was 24 % partial response in 6 patients, 56 % stable disease in 14 patients, and 20 % progressive disease in 5 patients. Sixteen patients (64 %) received second-line chemotherapy. The estimated median progression-free survival and median overall survival times were, respectively, 5.6 months (95 % CI 4.1-6.7 months) and 10.2 months (95 % CI 6.5-14.2 months). The major hematological toxicities were included grade 3/4 leucocytopenia in 8 patients (32 %), grade 3/4 neutropenia in 13 patients (52 %), and one patients (4 %) suffered grade 1 febrile neutropenia. The common grade 3/4 non-hematological toxicity was Anorexia, rash and fatigue, held the proportion of 12%, 16% and 12%, respectively. Conclusions: Gemcitabine and S-1 (GS) combination therapy showed promising activity with acceptable toxicities as first-line chemotherapy in Chinese patients with metastatic or advanced pancreatic cancer.

scholarly journals Phase II study of an oxaliplatin-based regimen for relapsed colon cancer patients treated with oxaliplatin-based adjuvant chemotherapy (INSPIRE study)

2021 ◽  
Author(s):  
Keiichiro Ishibashi ◽  
Toru Aoyama ◽  
Masahito Kotaka ◽  
Hironaga Satake ◽  
Yasushi Tsuji ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Adjuvant Chemotherapy ◽  
Cancer Patients ◽  
Sensory Neuropathy ◽  
Progression Free Survival ◽  
First Line ◽  
Secondary Endpoints ◽  
Grade 3 ◽  
Peripheral Sensory ◽  
Line Chemotherapy

Abstract Background The aim of this study was to evaluate the efficacy and safety of first-line chemotherapy with re-introduction of oxaliplatin (OX) more than 6 months after adjuvant chemotherapy including OX. Methods Stage II/III colon cancer patients with neuropathies of grade ≤ 1 who relapsed more than 6 months after adjuvant chemotherapy including OX were considered eligible. Eligible patients were treated with 5-fluorouracil, l-leucovorin and OX plus molecularly targeted agents or capecitabine and OX plus bevacizumab (BV) or S-1 and OX plus BV. The primary endpoint was the progression-free survival (PFS), and the secondary endpoints were the overall survival (OS), response rate (RR) and toxicity. Results A total of 50 patients were enrolled between September 2013 and May 2019. Twelve patients received 5-fluorouracil, l-leucovorin and OX (FOLFOX) plus BV, 21 patients received capecitabine and OX plus BV, 10 patients received S-1 and OX plus BV and 7 patients received FOLFOX plus cetuximab or panitumumab. The median PFS was 11.5 months (95% confidence interval [CI] 8.3–16.0), the median OS was 45.4 months (95% CI 37.4–NA), and the RR was 56.0% (95% CI 42.3–68.8). Adverse events of grade ≥ 3 that occurred in ≥ 5% of cases were neutropenia in 6 patients (12%), peripheral sensory neuropathy in 5 patients (10%), diarrhea in 4 patients (8%), hypertension in 4 patients (8%), anorexia in 3 patients (6%) and allergic reactions in 3 patients (6%). Conclusions First-line chemotherapy with re-introduction of OX more than 6 months after adjuvant chemotherapy including OX can be used safely with expected efficacy for relapsed colon cancer patients.

scholarly journals Real-world comparative effectiveness of nab-paclitaxel plus gemcitabine versus FOLFIRINOX in advanced pancreatic cancer: a systematic review

2019 ◽  
Vol 11 ◽  
pp. 175883591985036 ◽  
Author(s):  
Elena Gabriela Chiorean ◽  
Winson Y. Cheung ◽  
Guido Giordano ◽  
George Kim ◽  
Salah-Eddin Al-Batran
Keyword(s):  
Systematic Review ◽  
Pancreatic Cancer ◽  
Real World ◽  
Controlled Trial ◽  
Safety Data ◽  
Advanced Pancreatic Cancer ◽  
Progression Free Survival ◽  
First Line ◽  
Eligibility Criteria ◽  
Grade 3

Background: No clinical trial has directly compared nab-paclitaxel/gemcitabine (nab-P/G) with FOLFIRINOX (fluorouracil/leucovorin/oxaliplatin/irinotecan) in metastatic or advanced pancreatic cancer (mPC or aPC). We conducted a systematic review of real-world studies comparing these regimens in the first-line setting. Methods: Embase and MEDLINE databases through 22 January 2019, and Gastrointestinal Cancers Symposium 2019 abstracts were searched for real-world, retrospective studies comparing first-line nab-P/G versus FOLFIRINOX in mPC or aPC that met specific parameters. Studies with radiotherapy were excluded. Study quality was assessed using the Newcastle–Ottawa Scale. Results: Of 818 records initially identified, 35 were duplicates and 749 did not meet the eligibility criteria, mostly because they were either not comparative ( n = 356) or not first line ( n = 245). The remaining 34 studies (21 mPC; 13 aPC) assessed >6915 patients who received nab-P/G or FOLFIRINOX. In the studies identified, the median overall survival (OS) reached 14.4 and 15.9 months with nab-P/G and FOLFIRINOX, respectively, and median progression-free survival reached 8.5 and 11.7 months, respectively. Safety data were reported in 14 studies (2205 patients), including 8 single-institutional studies. In most single-institutional studies that reported safety data, rates were higher with FOLFIRINOX versus nab-P/G for grade 3/4 neutropenia (five of six studies) and febrile neutropenia (all three studies), while rates of grade 3/4 peripheral neuropathy were higher with nab-P/G in four of seven studies. Conclusions: Although FOLFIRINOX was associated with slightly longer median OS in more studies, the differences, when available, were not statistically significant. Therefore, a randomized, controlled trial is warranted. Toxicity profile differences represent key considerations for treatment decisions.

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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