Real-world outcomes of second-line ramucirumab plus paclitaxel in patients with advanced gastric or gastroesophageal junction adenocarcinoma: A nationwide retrospective study in Korea (KCSG-ST19-16).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 4056-4056
Author(s):  
Dae Young Zang ◽  
Hye Sook Han ◽  
Bum Jun Kim ◽  
Hee-Jung Jee ◽  
Young Ju Suh ◽  
...  
Keyword(s):  
Overall Survival ◽  
Retrospective Study ◽  
Adverse Events ◽  
Real World ◽  
Gastroesophageal Junction ◽  
Locally Advanced ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Real World Data

4056 Background: Ramucirumab as monotherapy or in combination with paclitaxel is a second-line treatment option recommended for patients with locally advanced unresectable or metastatic gastroesophageal junction (GEJ) or gastric adenocarcinoma. However, real-world data of large samples focused on ramucirumab plus paclitaxel in gastric cancer are limited. We conducted a nationwide retrospective study to evaluate the efficacy, safety, and factors potentially associated with survival in patients with gastric or GEJ adenocarcinoma who received second-line ramucirumab plus paclitaxel in a real-world setting. Methods: The study population comprised all patients with gastric or GEJ cancer who received ramucirumab plus paclitaxel in South Korea between May 1, 2018, and December 31, 2018. We included patients with advanced gastric or GEJ adenocarcinoma and disease progression after first-line platinum and fluoropyrimidine-containing combination chemotherapy. Results: A total of 1,063 patients with advanced gastric or GEJ adenocarcinoma who received ramucirumab plus paclitaxel were included. The objective response rate and disease control rate were 15.1% and 57.7%, respectively; the median progression-free survival was 4.03 months (95% CI, 3.80–4.27), and the median overall survival was 10.3 months (95% CI, 9.33–10.73). The common treatment-related adverse events (TRAEs) at any grade were neutropenia (44.7%), anemia (41.8%), neuropathy (29.1%), fatigue (25.9%), and anorexia (25.0%). Grade 3 or higher TRAEs with incidences of ≥5% were neutropenia (35.1%) and anemia (10.5%). Adverse events of special interest were infrequent, including hypertension (2.1%) and proteinuria (3.0%). Based on multivariate analysis, overall survival was negatively associated with Eastern Cooperative Oncology Group performance status ≥2, weight loss in the previous 3 months ≥10%, GEJ of primary tumor, poor or unknown histology grade, number of metastatic sites ≥3, presence of peritoneal metastasis, no prior gastrectomy, and time to second-line since first-line treatment < 6 months. Conclusions: Our large-scale, nationwide, real-world data analysis of an unselected real-world population added evidence for the efficacy and safety of second-line ramucirumab plus paclitaxel in patients with locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. Clinical trial information: NCT04192734.

scholarly journals Ramucirumab plus paclitaxel as second-line treatment in patients with advanced gastric or gastroesophageal junction adenocarcinoma: a nationwide real-world outcomes in Korea study (KCSG-ST19-16)

2021 ◽  
Vol 13 ◽  
pp. 175883592110428
Author(s):  
Hye Sook Han ◽  
Bum Jun Kim ◽  
Hee-Jung Jee ◽  
Min-Hee Ryu ◽  
Se Hoon Park ◽  
...  
Keyword(s):  
Overall Survival ◽  
Confidence Interval ◽  
Real World ◽  
Gastroesophageal Junction ◽  
Locally Advanced ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Real World Data ◽  
World Data

Background: Ramucirumab as monotherapy or in combination with paclitaxel is a second-line treatment option recommended for patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. However, real-world data from large study cohorts focused on ramucirumab plus paclitaxel in gastric cancer are limited. Methods: The study population comprised all patients with gastric or GEJ cancer who received ramucirumab plus paclitaxel in South Korea between 1 May 2018 and 31 December 2018. We included patients with advanced gastric or GEJ adenocarcinoma and disease progression after first-line platinum and fluoropyrimidine-containing combination chemotherapy. Results: In total, 1063 patients were included in the present study. The objective response rate and disease control rate were 15.1% and 57.7%, respectively. The median progression-free survival was 4.03 months (95% confidence interval, 3.80–4.27) and the median overall survival was 10.03 months (95% confidence interval, 9.33–10.73). Grade 3 or higher treatment-related adverse events with incidence of ⩾5% were neutropenia (35.1%) and anemia (10.5%). Based on multivariable analysis, overall survival was negatively associated with Eastern Cooperative Oncology Group performance status ⩾2, weight loss ⩾10% in the previous 3 months, GEJ of primary tumor, poor or unknown histologic grade, number of metastatic sites ⩾3, presence of peritoneal metastasis, no prior gastrectomy, and time to second-line since first-line treatment <6 months. Conclusion: Our large-scale, nationwide, real-world data analysis of an unselected real-world population adds evidence for the efficacy and safety of second-line ramucirumab plus paclitaxel in patients with locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma.

Determinants of first-line treatment selection in advanced pancreatic ductal adenocarcinoma (PDAC).

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 468-468
Author(s):  
Hui-Li Wong ◽  
Ying Wang ◽  
Yaling Yin ◽  
Hagen F. Kennecke ◽  
Winson Y. Cheung ◽  
...  
Keyword(s):  
Overall Survival ◽  
Locally Advanced ◽  
Treatment Selection ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Second Line Therapy ◽  
Line Therapy ◽  
The Impact ◽  
First Line Treatment

468 Background: Chemotherapy options currently available for the first-line treatment of advanced PDAC include FOLFIRINOX (FX), gemcitabine with nab-paclitaxel (GP) and single agent gemcitabine (Gem). GP was introduced most recently and funded for clinical use in British Columbia (BC) in September 2014. In this retrospective analysis, we explore the impact of GP availability on first-line treatment selection and overall survival (OS) in advanced PDAC. Methods: The BC Cancer Agency provincial pharmacy database was used to identify patients (pts) who started FX, GP or Gem between January and August 2014 (pre-GP) or January and August 2015 (post-GP). Pts were eligible for inclusion if they received at least one cycle of first-line therapy for locally advanced or metastatic PDAC. Clinical data were extracted from electronic medical records. OS was defined as time from diagnosis of advanced PDAC to death and compared by treatment era, adjusting for age, ECOG, comorbidities, disease extent and baseline CA19-9. Results: 286 pts fulfilled eligibility criteria: 88 (31%) with locally advanced and 198 (69%) with metastatic disease. 131 and 155 pts were treated in the pre- and post-GP eras respectively. Prior to GP approval, 44% and 49% of pts received Gem and FX; this decreased to 21% and 33% after GP funding, with 46% of pts receiving GP in the latter period. Nine (7%) pts received GP in the pre-GP era, either through self-pay or addition of nab-paclitaxel after approval. There were no significant differences in pt characteristics across both eras. 46% of pts who received GP post approval had ECOG ≥ 2. The proportion of pts receiving second-line therapy was lower in the post-GP era (22% vs. 38%). Median OS in the post-GP era was 8.1 vs. 10.1 months in the pre-GP era; adjusted HR 1.28 (95% CI 0.96–1.71). Pts with ECOG ≥ 2 who received GP had a median OS of 6.5 months. Conclusions: After GP was funded, it became the preferred first-line regimen for advanced PDAC. Its more frequent use instead of FX did not appear to compromise overall survival even though a substantial proportion of pts were ECOG ≥ 2 and few pts received second-line therapy.

A randomized phase II study of oxaliplatin/5-FU (mFOLFOX) versus irinotecan/5-FU (mFOLFIRI) chemotherapy in locally advanced or metastatic biliary tract cancer refractory to first-line gemcitabine/cisplatin chemotherapy.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 4603-4603
Author(s):  
Jin Won Kim ◽  
Koung Jin Suh ◽  
Ji-Won Kim ◽  
Jin Hyun Park ◽  
Ki Hwan Kim ◽  
...  
Keyword(s):  
Adverse Events ◽  
Biliary Tract ◽  
Biliary Tract Cancer ◽  
Locally Advanced ◽  
Ampulla Of Vater ◽  
Tumor Location ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Tract Cancer

4603 Background: In locally advanced or metastatic biliary tract cancer (BTC), second-line chemotherapy is challenging after progression from first-line gemcitabine/cisplatin, although mFOLFOX has been proven to be superior to active symptom control in ABC-06 trial. Irinotecan is an active drug in other gastrointestinal cancers. This study evaluated whether mFOLFIRI was superior to mFOLFOX in second-line treatment of BTC. Methods: Patients diagnosed with BTC with disease progression after prior gemcitabine/cisplatin were randomized (1:1) to either mFOLFOX (oxaliplatin 100mg/m2 over 2 hours, leucovorin 100mg/m2 over 2 hours, 5-fluorouracil 2400mg/m2 over 46 hours, every 2 weeks) or mFOLFIRI (irinotecan 150mg/m2 over 2 hours, leucovorin 100mg/m2 over 2 hours, 5-fluorouracil 2400mg/m2 over 46 hours). Randomization was stratified by tumor location (intrahepatic vs extrahepatic vs gallbladder vs ampulla of vater) and ECOG performance status (0, 1 vs 2). Primary end-point was overall survival (OS) rate at 6 months. Results: In total, 120 patients were enrolled and 114 patients were treated (mFOLFOX:57, mFOLFIRI:57). Median age was 63 years old. Most patients had ECOG 0/1 (89.5%). Tumor location was intrahepatic in 47 patients (41.2%), extrahepatic in 27 (23.7%), gallbladder in 35 (30.7%) and ampulla of vater in 5 (4.4%). At the median follow-up duration of 10.7 months (95% CI, 8.2-13.2), 6-month OS rate was 58.1% in mFOLFOX and 46.0% in mFOLFIRI. Of 102 evaluable patients (mFOLFOX:51, mFOFIRI:51), objective response rate and disease control rate were 5.9% (95% CI, 0-12.4) and 64.7% (95% CI, 51.6-77.8) in mFOLFOX and 3.9% (95% CI, 0-9.2) and 58.8% (95% CI, 45.3-72.3) in mFOLFIRI. Median progression-free survival was 2.8 months (95% CI, 2.3-3.3) in mFOLFOX and 2.1 months (95% CI, 1.3-2.9) in mFOLFIRI (p = 0.682). Median OS was 6.6 months (95% CI, 5.6-7.6) in mFOLFOX and 5.9 months (95% CI, 4.3-7.5) in mFOLFIRI (p = 0.887). The most common grade 3/4 adverse events were neutropenia (26.3%) and AST/ALT elevation (15.8%) in mFOLFOX and neutropenia (24.6%) and anemia (17.5%) in mFOLFIRI. Peripheral neuropathy (36.8%) and thrombocytopenia (35.1%) in mFOLFOX and vomiting (19.3%) and cholangitis (10.5%) in mFOLFIRI occurred more frequently. No chemotherapy-related deaths were reported. Conclusions: In second-line treatment of BTC, mFOLFIRI was tolerable But, mFOLFIRI was not superior to mFOLFOX. Adverse events were different between two groups. Clinical trial information: NCT03464968 .

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.

scholarly journals Real-world Data Analysis of Immunotherapy in Advanced Lung Cancer

2021 ◽  
Author(s):  
Meiling Sun ◽  
Huaijun Ji ◽  
Ning Xu ◽  
Peng Jiang ◽  
Tao Qu ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Adverse Events ◽  
Real World ◽  
Treatment Cycle ◽  
Advanced Lung Cancer ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Short Term ◽  
First Line Treatment

Abstract BackgroundThis study was designed to investigate the clinical application, efficacy, and safety of immune checkpoint inhibitors (ICIs) in the treatment of lung cancer in the real world. MethodsA retrospective, observational analysis was conducted on patients treated with ICIs in four tertiary hospitals in the region from January 2015 to March 2021, to evaluate the clinical efficacy of ICI single-agent or combined chemotherapy and anti-vascular drugs in the first-line or second-line treatment of patients with advanced lung cancer. ResultsThree hundred and fifteen patients were enrolled in this study. The objective response rate (ORR) and disease control rate (DCR) were 36.5% (115/315) and 94.0% (296/315), respectively, the median progression-free survival (PFS) was 10.8 months, and the median overall survival (OS) was not reached. A total of 165 patients received ICI as the first-line treatment, the median treatment cycle was 8 cycles (2-20 cycles), the short-term efficacy ORR was 41.2%, DCR was 94.5%, and the median PFS was 12.0 months. 150 patients received ICI treatment as second-line treatment, the median treatment cycle was five cycles (2-10 cycles), the short-term efficacy ORR was 31.3%, DCR was 93.3%, and the median PFS was 10.0 months. There were no statistically significant differences in ORR, DCR, or median PFS with ICI as the first-line treatment compared with the second-line treatment(P>0.05). The results of subgroup analysis showed that Karnofsky performance status (KPS) score, EGFR mutation status, and number of treatment lines were not correlated with median PFS((P>0.05). However, there were statistically significant differences in programmed death-ligand 1(PD-L1) expression, pathological types, hormone interference, and antibiotic (Abx) treatment among all groups (P< 0.05). In terms of safety, the overall incidence of adverse reactions in 315 patients was 62.5%, and the incidence of immune-related adverse events(irAEs) was 13.7%. Grade 1-2 and 3-4 incidence of adverse events were 34.9% and 27.65%, respectively. There were four patients who experienced fatal irAEs, two cases were liver damage leading to liver failure, one case was immune related pneumonia, and one case was immune related myocarditis. ConclusionIn the real world, immunotherapy has a good effect on patients with advanced lung cancer and significantly improves ORR and PFS.

CML-296: First-Line Treatment Outcomes of CML Patients in a Real-World Data Setting in Lebanon

2021 ◽  
Vol 21 ◽  
pp. S332-S333
Author(s):  
Fadi Nasr ◽  
Intissar Yehia ◽  
Reem El Khoury ◽  
Saada Diab ◽  
Ahmad Al Ghoche ◽  
...  
Keyword(s):  
Treatment Outcomes ◽  
Real World ◽  
Line Treatment ◽  
First Line ◽  
Real World Data ◽  
World Data ◽  
First Line Treatment

Stent-over-sponge (SOS): a novel technique complementing endosponge therapy for foregut leaks and perforations

Endoscopy ◽  
2017 ◽  
Vol 50 (02) ◽  
pp. 148-153 ◽  
Author(s):  
Piero Valli ◽  
Joachim Mertens ◽  
Arne Kröger ◽  
Christoph Gubler ◽  
Christian Gutschow ◽  
...  
Keyword(s):  
Adverse Events ◽  
Success Rate ◽  
Vacuum Therapy ◽  
Line Treatment ◽  
Second Line ◽  
Metal Stent ◽  
First Line ◽  
Novel Technique ◽  
Upper Gastrointestinal ◽  
First Line Treatment

Abstract Background and study aims Endoluminal vacuum therapy (EVT) has evolved as a promising option for endoscopic treatment of foregut wall injuries in addition to the classic closure techniques using clips or stents. To improve vacuum force and maintain esophageal passage, we combined endosponge treatment with a partially covered self-expandable metal stent (stent-over-sponge; SOS). Patients and methods Twelve patients with infected upper gastrointestinal wall defects were treated with the SOS technique. Results Indications for SOS were anastomotic leakage after surgery (n = 11) and chronic foregut fistula (n = 1). SOS treatment was used as a first-line treatment in seven patients with a success rate of 71.4 % (5/7) and as a second-line treatment after failed previous EVT treatment in five patients (success rate 80 %; 4/5). Overall, SOS treatment was successful in 75 % of patients (9/12). No severe adverse events occurred. Conclusion SOS is an effective method to treat severely infected foregut wall defects in patients where EVT has failed, and also as a first-line treatment. Comparative prospective studies are needed to confirm our preliminary results.

Penpulimab in combination with anlotinib as first-line treatment in advanced nonsquamous non-small-cell lung cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e21072-e21072
Author(s):  
Baohui Han ◽  
Jianhua Chen ◽  
Ziping Wang ◽  
Xingya Li ◽  
Lin WANG ◽  
...  
Keyword(s):  
Overall Survival ◽  
Combination Therapy ◽  
Advanced Nsclc ◽  
Locally Advanced ◽  
Drug Binding ◽  
Line Treatment ◽  
First Line ◽  
Anaplastic Lymphoma ◽  
Metastatic Nsclc ◽  
First Line Treatment

e21072 Background: Penpulimab is a human IgG1 monoclonal antibody (mAb) directed against human programmed cell death-1 (PD-1). Penpulimab, with its unique binding epitope, was engineered to eliminate Fc-mediated effector function that compromises anti-tumor immune cell function, and to optimize receptor occupancy by improving duration of drug binding. As a promising multi-target tyrosine kinase inhibitor (TKI), anlotinib significantly improved overall survival in advanced NSCLC patients (pts) in the phase 3 trial ALTER0303. Antiangiogenesis therapy combined with PD-1/PD-L1 inhibitors has shown excellent efficacy in advanced NSCLC pts. This is the trial evaluating chemo-free combination of penpulimab plus anlotinib in treatment-naive advanced NSCLC pts regardless of PD-L1 expression (NCT03866980). Methods: Pts with previously untreated, stage IIIB/IIIC/IV non-squamous NSCLC without sensitizing mutation of the epidermal growth factor receptor (EGFR) gene or translocation of the anaplastic lymphoma kinase (ALK) gene were enrolled. Eligible pts received penpulimab 200mg Q3W in combination with anlotinib 12mg QD (2 weeks on 1 week off) until loss of clinical benefit or unacceptable toxicity. The primary endpoint was progression-free survival (PFS). Secondary endpoints included ORR, disease control rate (DCR), duration of response (DoR) and overall survival. Results: As of January 13, 2021, 26 pts had received the combination therapy of penpulimab plus anlotinib (median age 59.5yrs [range 30-71], 76.9% male, 76.9% ECOG PS 1), with a median treatment duration of 3.5 months. Of 21 pts who have had at least one tumor assessment, the ORR was 57.1% (12 PRs) and DCR was 90.5% (12 PRs, 7 SDs). Median PFS has not been reached, and eleven responders remain in response. Treatment-related adverse events (TRAEs) occurred in 53.8% of pts (≥G3 TRAEs occurred in 15.4% [4/26]). Treatment-related SAEs occurred in 15.4% [4/26], and 7.7% of pts [2/26] had drug interruption or discontinuation due to TRAEs. Most common TRAEs (≥15%) were ALT increased, AST increased, hyperthyroidism and hypertension (15.4% each). Conclusions: The combination of penpulimab plus anlotinib as first-line treatment for locally advanced/metastatic NSCLC showed the promising efficacy with a manageable safety profile, thereby suggesting that this combination therapy may be a viable chemo-free treatment strategy for locally advanced/metastatic NSCLC pts. Clinical trial information: NCT03866980.

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