Clinical outcomes of FOLFIRINOX and gemcitabine/nab-paclitaxel in the real world setting.

440 Background: The incidence of pancreatic cancer is increasing in developed countries. Though FOLFIRINOX (FFX) and gemcitabine plus nab-paclitaxel (GNP) are associated with increased toxicity and are addressed to a well selected population, there seems to have been a rapid incorporation of these regimens in the real world. Overall survival (OS) was 11.1 months for FFX and 8.5 months for GNP. Survival rate at 18 m with FFX was 18.6%; at 24 m with GNP was 9%. Questions have arisen about external validity of original trials and how could these regimens impact overall survival since they are available nowadays for second line settings. Methods: This is a retrospective study. The Departments of Pharmacy of 5 Spanish hospitals generated the listings of patients (pts) treated in first line with the new regimens, namely FFX or GNP. To avoid bias related to non-prospective data collection, we restricted the analysis to survival data, serious toxicity and 2nd line options. Results: From Jan 2012 to Dec 2016, a total of 136 pts (M/F 52/48 %) were treated. Med age 63 y (38-83 y), 95% adenocarcinoma. 48% head of pancreas. ECOG 88% 0-1. 36 % locally advanced and 64% metastatic. 88% had liver mets. In the 1st line 64% were treated with FFX and 36% with GNP. 5 (3,7%) pts died in the first 3 months of treatment, because of infectious complications. 16 pts were operated after chemotherapy. 60% of the pts could receive a 2nd line (43% GNP, 25% FFX, 32% other). 27 pts (19.8%) were treated with a 3rd line. More pts treated with FFX required G-CSF (85% vs 15%). The median OS was 13 months with no differences between regimens. Survival rate at 30 months was 25% for both regimens. Elevated Ca 19.9 levels and Neutrophil-Lymphocyte ratio (NLR) increased the risk of death during the first-line. Conclusions: Originally reported OS is not only reproduced but improved in the real world despite a less strict inclusion of pts. 25% of patients remain alive 30 months after diagnosis. Superiority could not be demonstrated for any of the schemes. The availability of both regimens seems to dilute the potential differences and it is not so important the election of the 1st line. Both NLR and Ca 19.9 level predicted risk of death during the 1st line impairing the possibility of being treated in 2nd line.

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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)

Therapeutic Advances in Medical Oncology ◽

10.1177/17588359211042812 ◽

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.

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Clinical outcomes of FOLFIRINOX and gemcitabine-nab-paclitaxel for metastatic pancreatic cancer in the real-world setting.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.4_suppl.656 ◽

2020 ◽

Vol 38 (4_suppl) ◽

pp. 656-656

Author(s):

Fabio Franco ◽

Jose Ignacio Martin Valades ◽

David Marrupe ◽

Juan Carlos Camara ◽

David Gutierrez Abad ◽

...

Keyword(s):

Pancreatic Cancer ◽

Overall Survival ◽

Elderly Population ◽

Survival Rates ◽

The Elderly ◽

Metastatic Pancreatic Cancer ◽

Second Line ◽

First Line ◽

The Real ◽

Ca 19.9

656 Background: Randomized clinical trials have established new chemotherapeutic standards of care for metastatic pancreatic cancer, namely FOLFIRINOX (FFX) and gemcitabine + nab-paclitaxel (GNP) after demonstrating a significant and relevant increase of overall survival. However, there are some important uncertainties regarding how many patients are candidate to each of the two new regimens in the real life and how is the pattern of use in the elderly population. Methods: This is a retrospective study. Departments of Pharmacy of 7 Spanish hospitals generated the listings of patients (pts) treated in first line with these new regimens (FFX or GNP). Non-metastatic patients were excluded. An exploratory analysis was performed in the elderly population. Results: From Jan 2012 to Dec 2017, a total of 119 pts (M/F 58/42 %) were treated. Med age 63 y (38-83 y), 99% adenocarcinoma. 40% located in the head of pancreas. ECOG 87% 0-1. 89% had liver mets. In the 1st line 49.6% were treated with FFX and 50.4% with GNP. 53% of the pts could receive a 2nd line (82% after FFX 75% after GNP). The median OS was 12 months with no statistically significant differences between both regimens (12,7m for FFX vs 10,2 m for GNP). Elevated Ca 19.9 levels and Neutrophil-Lymphocyte ratio (NLR) increased the risk of death. Patients who received both regimens in first/second line had a median OS longer than 15 months whichever the sequence. 32 patients (27%) were older than 70 yo. 13 (41%) were treated with FFX and 19 (59%) with GNP. The median OS for patients older than 70 was 9.5m versus 12.3m for patients younger than 70. Conclusions: In our setting the use of FFX and GNP for treating metastatic pancreatic cancer is quite similar. Superiority could not be demonstrated for any of the schemes in first-line. Overall survival was determined by basal Ca 19.9 and NLR. Patients receiving both regimens (FFX or GNP) in first/second line whichever the sequence, exhibited the best survival rates. In our series elderly patients had poor survival rates.

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Overall survival (OS) among Medicare beneficiaries receiving sipuleucel-T (sip-T) versus oral treatment for metastatic castration-resistant prostate cancer (mCRPC).

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.6_suppl.42 ◽

2020 ◽

Vol 38 (6_suppl) ◽

pp. 42-42

Author(s):

Rana R. McKay ◽

Scott C. Flanders ◽

Christine Ferro ◽

Kate Fitch ◽

Michael Fabrizio ◽

...

Keyword(s):

Prostate Cancer ◽

Overall Survival ◽

Real World ◽

Oral Treatment ◽

Castration Resistant Prostate Cancer ◽

Opioid Use ◽

First Line ◽

Risk Of Death ◽

Radium 223 ◽

Oral Agents

42 Background: Since the mCRPC treatment landscape is evolving, we examined real-world use and outcomes of sipuleucel-T (sip-T) and oral agents (abiraterone acetate and enzalutamide) in men with mCRPC. Methods: Using Medicare FFS Identifiable Research data, we identified mCRPC men with a qualifying prostate cancer diagnosis (ICD-9 185, ICD-10 C-61) and an initial treatment claim (abiraterone, cabazitaxel, docetaxel, enzalutamide, radium 223, sip-T) in 2014. Continuous Part A, B, and D eligibility and no HMO enrollment was required through 2017 or until death. mCRPC index date is the date of a mCRPC therapeutic claim. Using 4 groups (sip-T first line, oral first line, sip-T any line, and oral any line [no sip-T]), survival was estimated using Kaplan-Meier methods (unadjusted). Hazard ratios (HR) were estimated using Cox’s proportional hazards regression modeling. Results: During 2014, 14,482 eligible men had mCRPC drug claims. We studied 6,853 naïve mCRPC men with no treatment claim in the prior 12 months. Over 150 permutations of anti-cancer agents were identified. See table for patient characteristics. Sip-T was used 2+ line in 4.5% of men receiving orals 1st. Median overall survival was longer for men who received sip-T, regardless if used 1st line (35 mo) or in any line (35 mo), compared with oral 1st line use (21 mo) or an oral any time without sip-T (21 mo). Similar survival was seen after adjusting for baseline opioid use. While most received sip-T as 1st line, survival rates were higher in men receiving sip-T in any line (48%) compared to men who never received any sip-T (29%). Conclusions: In this analysis, sip-T use was associated with a 45% reduction in risk of death and 14 mo survival benefit in the Medicare FFS population regardless of when used. Real-world analyses like this provide insight into how to optimize sip-T use to treat prostate cancer.[Table: see text]

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Updated Overall Survival Data and Predictive Biomarkers of Sintilimab Plus Pemetrexed and Platinum as First-Line Treatment for Locally Advanced or Metastatic Non-squamous NSCLC in the Phase III ORIENT-11 Study

Journal of Thoracic Oncology ◽

10.1016/j.jtho.2021.07.015 ◽

2021 ◽

Author(s):

Yunpeng Yang ◽

Jiya Sun ◽

Zhehai Wang ◽

Jian Fang ◽

Qitao Yu ◽

...

Keyword(s):

Overall Survival ◽

Survival Data ◽

Locally Advanced ◽

Predictive Biomarkers ◽

Phase Iii ◽

Line Treatment ◽

First Line ◽

First Line Treatment

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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).

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.4056 ◽

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.

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AVASTERB OUEST: A prospective cohort study of unresectable metastatic colon cancer treated successively by FOLFIRI bevacizumab and cetuximab irinotecan

Journal of Clinical Oncology ◽

10.1200/jco.2009.27.15_suppl.e15103 ◽

2009 ◽

Vol 27 (15_suppl) ◽

pp. e15103-e15103

Author(s):

J. Metges ◽

E. Gamelin ◽

R. Faroux ◽

V. Klein ◽

G. Ganem ◽

...

Keyword(s):

Overall Survival ◽

Real World ◽

Response Rate ◽

Survival Rates ◽

Metastatic Colon Cancer ◽

Time To Progression ◽

First Line ◽

Curative Intent ◽

The Real

e15103 Background: Bevacizumab and cetuximab regimen are approuved since 2005 in Europe for Metastatic Colorectal Cancer Patients (MCCP). Very few studies have reported data concerning the sequence (FOLFIRI BEVA and after failure CETUXIMAB- CAMPTO) in MCCP from the real world. Methods: Since 2003, in west of France, (Bretagne-Pays de Loire),a network called OMIT(Observatoire des Médicaments et Innovations Thérapeutiques) directed by Regional Health Agencies has been created. This structure gathered prospectively data from MCCP treated with targeted therapies. Since 2006, a cohort of MCCP treated successively by FOLFIRI BEVACIZUMAB (same protocol : same dose) as first line to progression or unacceptable toxicity and CETUXIMAB- CAMPTO after the first line failure was constitued (AVASTERB cohort). Criteria for initial unresectability of metastic lesions was based on investigator's evaluations during local comitee (surgeons and oncologists). In order to have a large follow up, the 35 first patients of the cohort were studied in this abstract.Age, sex, response rate to the different regimens,secondary metastatic lesion resection, time to progression to the different regimens, follow up and overall survival are the criterias studied. Results: Median age 60 years (49–83), Males : 60%, colon 71%,rectum: 17%, colorectal jonction :12%.Response rate(OR+SD)with Folfiri Bevacizumab : 45.7%. 17% of the patients underwent hepatic surgery with curative intent (all during Folfiri bevacizumab) Time to progression with Bevacizumab : 6 months. Fifty eight percent of the patients are still alive with a median follow up of 25 months (11–29)Median overall survival was not reached.The 12 months and 24 months overall survival rates are respectively 71.4% and 45.7% (date of point: 01/01/2009). Actualisation of the data will be provided during the meeting Conclusions: The results from this prospective unselected cohort of MCCP treated with the sequence FOLFIRI BEVA and after failure CETUX-CAMPTO from the real world show promising TTP, and overall survival. The study of the Kras mutation and others biomarkers could improve these results by personalization of the treatment. This part of our study is actually ongoing. No significant financial relationships to disclose.

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Pancreatic cancer: Survival in clinical trials versus the real world.

Journal of Clinical Oncology ◽

10.1200/jco.2016.34.4_suppl.216 ◽

2016 ◽

Vol 34 (4_suppl) ◽

pp. 216-216 ◽

Cited By ~ 3

Author(s):

Reith Roy Sarkar ◽

Rayna Matsuno ◽

James Don Murphy

Keyword(s):

Pancreatic Cancer ◽

Clinical Trial ◽

Overall Survival ◽

Clinical Trials ◽

Pancreatic Adenocarcinoma ◽

Median Survival ◽

Real World ◽

Locally Advanced ◽

The Real ◽

Survival Differences

216 Background: Physicians often use clinical trial data to estimate expected survival for their patients, however clinical trial results may not generalize to a broader population. Given the need for accurate prognostication, we examined whether the survival of clinical trial pancreatic adenocarcinoma patients was similar to “real world” patients. Methods: We conducted a literature search using Pubmed to identify pancreatic adenocarcinoma Phase III trials published between 2005 and 2012. We excluded secondary or pooled analyses, trials with second-line treatments, and non-randomized studies. We compared clinical trial patients to a cohort of patients from the Surveillance, Epidemiology, and End Results (SEER) program, matching for diagnosis year, age and stage of disease. We evaluated for differences in median survival, 1-year survival, and 2-year survival. Results: We identified 27 trials (3 metastatic, 16 mixed metastatic and locally advanced, 3 locally advanced, and 5 resectable) that fit our search criteria, consisting of 8,438 patients. Compared to SEER the median survival was higher in 98% of the individual clinical trial arms by an average of 3.7 months (p = 0.001). The 1-year overall survival rate was higher in 100% of the clinical trial arms by an average of 12.3% (p <.0001). The 2-year overall survival was higher in 76% of the clinical trial arms by an average of 5.1% (p <.0001). The survival differences between SEER and clinical trials were greatest for patients with metastatic pancreatic cancer. Conclusions: We found that clinical trial patients have profoundly improved survival compared to patients in the SEER database, suggesting that clinical trial survival estimates may not generalize to “real world” patients with pancreatic cancer. Patient performance status, underlying comorbidity, and differences in treatment could not be assessed in SEER, though these factors likely explain a portion of the survival differences. These findings suggest that physicians should use caution when extrapolating survival estimates from clinical trials to the real world.

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Overall survival and treatment patterns among real-world patients with locally advanced or metastatic urothelial carcinoma treated with first-line therapy.

Journal of Clinical Oncology ◽

10.1200/jco.2018.36.6_suppl.464 ◽

2018 ◽

Vol 36 (6_suppl) ◽

pp. 464-464

Author(s):

Jason C Simeone ◽

Beth L Nordstrom ◽

Ketan Patel ◽

Alyssa B Klein ◽

Laura Horne

Keyword(s):

Overall Survival ◽

Real World ◽

Locally Advanced ◽

First Line ◽

First Line Therapy ◽

Real World Setting ◽

Line Therapy ◽

Platinum Based Chemotherapy ◽

Metastatic Urothelial Carcinoma

464 Background: Although platinum-based chemotherapy has been the standard of care for the treatment of locally advanced or metastatic urothelial carcinoma (UC), overall survival (OS) remains poor. Real world data on the treatment patterns for UC and effectiveness of these treatments are limited. Methods: Patients with locally advanced or metastatic UC who received first line therapy were identified from the Flatiron Oncology electronic medical record database from 2011–2016; patients who previously received immunotherapy treatment were excluded. Treatment characteristics included the most frequently administered first-line regimens in the study cohort and the time from advanced/metastatic diagnosis to start of first-line therapy. Median OS from the start of first-line therapy was calculated using Kaplan-Meier curves and 95% confidence intervals (CI) are presented. Results: Of 1,811 included patients who met study inclusion and exclusion criteria, the mean age was 70.4 ± 9.5 years, and 73.2% were male. Fewer than 3% of patients were tested for PD-L1 during follow-up. Platinum-based chemotherapy was the most commonly prescribed first-line treatment and immunotherapy was used in 1.3% of first-line regimens (Table 1); patients received a median of one treatment line during follow-up. The median OS was 12.7 months (95% CI: 11.8–13.5) from initiation of first-line therapy. Conclusions: Overall survival among locally advanced/metastatic UC patients who received first-line therapy in a real-world setting was approximately one year. As immunotherapy treatment for UC becomes more common, the impact on OS in the real world setting remains to be seen. [Table: see text]

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