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.

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.

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

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.

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

2021 ◽  
Vol 21 ◽  
pp. S226
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

Survival impact among occidental patients with metastatic gastric cancer (mGC) treated with ramucirumab as second line treatment (2L): Local experience of a teaching hospital in Chile.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16007-e16007
Author(s):  
Carlos Salinas ◽  
Olga Barajas ◽  
Luis Villanueva ◽  
Rodrigo Vasquez ◽  
Monica Ahumada
Keyword(s):  
Real World ◽  
Performance Status ◽  
Signet Ring Cell ◽  
Response To Treatment ◽  
Line Treatment ◽  
First Line ◽  
Local Data ◽  
Real World Data ◽  
World Data ◽  
First Line Treatment

e16007 Background: GC is frequent in Chile, with an incidence of 7.8% and a mortality rate of 11.6% in 2020. Late diagnosis continues to be one of the most important problems, although treatments in advanced stages have experienced important advances in the last 6 years. REGARD and RAINBOW trials showed an increase in median OS when using Ramucirumab alone or in combination with Paclitaxel of 5,2 and 9,4 mths respectively. Although this therapy is not covered by our Public Health Insurance, there are some patients that they can access. Also, there are not too many reports in LATAM pts so we present our local real world data. Methods: We conducted a retrospective study of local data from patients diagnosed with mGC who progressed with standard first-line treatment and were treated with ramucirumab-based regimens from January 2015 to January 2021. Clinical factors were recorded baseline, characteristics of therapy and AE related to toxicity. Toxicity was assessed by CTCAE v5.0 and response to treatment by RECIST 1.1. Results were analyzed by measuring time to progression and survival. Results: The search resulted in 9 pts, 6 men and 3 women between 38 and 72 years (median 59 years). 66% were in ECOG 1 performance status and 33% in ECOG 2, with a median BMI of 23 kg / m2. 33% were smokers and all had some other comorbidity as a medical history. All tumors were adenocarcinomas and 33% had a signet ring cell component on histology. Only one tumor was HER2 +++ and all were MSS (by IHC). The most common first-line treatment received before progression was FOLFOX; 4 to 12 cycles; 8 cycle average. All patients were treated with paclitaxel-ramucirumab as 2L (4 to 19 cycles, mean of 5 cycles). 67% of patients achieved stable disease with the best response. During the follow-up period, 8 patients experienced disease progression in an average of 6.7 months, who switched to 3L with Nivolumab. Relapses during 2L were in the peritoneum and 55% in other sites as well. Only two patients discontinued paclitaxel treatment after 4 cycles due to intolerance and continued to receive Ramucirumab. 44% developed grade 3 toxicities: 50% of them due to taxane-related peripheral neuropathy. Grade 4 or 5 toxicity was not reported. 50% of patients were alive at 6 months of treatment. Conclusions: In our country and LATAM, GC still has a significant medical and socioeconomic burden. Its incidence is still one of the highest in the world, most patients are diagnosed in the metastatic stage and face treatment in deficient PS. In this context, our local real-world data showed consistency with what the literature says, although more data remains to accumulate and describe.

Head-to-head comparison of first-line FOLFIRINOX versus gemcitabine plus nabpaclitaxel (GN) in advanced pancreatic cancer (APC): A target trial emulation using Canadian real-world data.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18713-e18713
Author(s):  
Devon J. Boyne ◽  
Darren Brenner ◽  
Alind Gupta ◽  
Eric Mackay ◽  
Paul Arora ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Median Survival ◽  
Real World ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Medical Decision ◽  
Target Trial ◽  
Real World Data ◽  
World Data

e18713 Background: When randomized trials are not available, observational real-world data can be used to emulate a (hypothetical) target trial. The procedure starts with the specification of the protocol of the target trial, whose components are then explicitly emulated using observational data. This approach prevents biases that are common when using more conventional methods for real-world data. Advanced pancreatic cancer represents an opportunity for trial emulation since two main frontline therapies, FOLFIRINOX and GN, have never been directly compared in a randomized fashion. The choice between the two regimens is largely based on physician discretion and patient preference rather than direct comparison of effectiveness. Methods: We emulated a target trial using linked data from the provincial cancer registry, electronic health records and various administrative databases from Alberta, Canada. Eligible individuals had locally advanced or metastatic pancreatic cancer diagnosed between Jan. 2015- Dec. 2018, no prior treatment, and adequate hematologic and serum creatinine values. They were followed from diagnosis until March 2020, death, or date of last known contact with the healthcare system. We estimated the effect of initiating FOLFIRINOX vs. GN within 8 weeks of diagnosis on overall survival. Cloning, artificial censoring, and inverse probability weighting were used to address unknown treatment assignment at baseline, non-adherence, and confounding. Adjusted Kaplan-Meier survival curves and hazard ratios were estimated. Results: Of 298 eligible individuals, 70 adhered to the FOLFIRINOX strategy and 147 to the GN strategy. The mean age was 65 years, 173 (58%) were male, and 247 (83%) had metastatic disease. The adjusted median survival, 1-year survival, and 2-year survival for FOLFIRNOX was 8.2 months (95% CI: 5.3 to 9.4), 36.9% (22.2 to 55.8), and 14.1% (4.8 to 32.2), respectively; and for GN was 4.8 months (3.3 to 5.3), 22.2% (13.6 to 35.9), and 4.7% (1.7 to 13.0), respectively. The adjusted difference in median survival was 3.4 months (0.6 to 11.1) and the adjusted hazard ratio was 0.79 (0.56 to 1.05). Conclusions: Target trial emulations can help to inform medical decision making in situations where head-to-head randomized trial data are unavailable or unfeasible. Findings from this real-world trial emulation suggest improved overall survival with FOLFIRINOX over GN.

P16.05 Real World Data of First-Line Treatment With Pembrolizumab for Highly PD-L1-Expressing NSCLC

2021 ◽  
Vol 16 (10) ◽  
pp. S1017
Author(s):  
M. Kobayashi ◽  
H. Mizugaki ◽  
Y. Ikezawa ◽  
R. Morita ◽  
K. Tateishi ◽  
...  
Keyword(s):  
Real World ◽  
Line Treatment ◽  
First Line ◽  
Real World Data ◽  
World Data ◽  
First Line Treatment
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