scholarly journals Results of the observational prospective RealFLOT study

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Elisa Giommoni ◽  
Daniele Lavacchi ◽  
Giuseppe Tirino ◽  
Lorenzo Fornaro ◽  
Francesco Iachetta ◽  
...  
Keyword(s):  
Real World ◽  
Response Rate ◽  
Postoperative Mortality ◽  
Disease Free Survival ◽  
Complete Response ◽  
Postoperative Phase ◽  
World Population ◽  
Real World Data ◽  
Unselected Population

Abstract Background Perioperative FLOT (5-fluorouracil, oxaliplatin and docetaxel) has recently become the gold standard treatment for fit patients with operable gastric (GC) or gastroesophageal (GEJ) adenocarcinoma, getting a 5-year overall survival (OS) of 45%, over 23% with surgery alone. Methods RealFLOT is an Italian, multicentric, observational trial, collecting data from patients with resectable GC or GEJ adenocarcinoma treated with perioperative FLOT. Aim of the study was to describe feasibility and safety of FLOT, pathological complete response rate (pCR), surgical outcomes and overall response rate (ORR) in an unselected real-world population. Additional analyses evaluated the correlation between pCR and survival and the prognostic role of microsatellite instability (MSI) status. Results Of 206 patients enrolled that received perioperative FLOT at 15 Italian centers, 124 (60.2%) received at least 4 full-dose cycles, 190 (92.2%) underwent surgery, and 142 (68.9%) started the postoperative phase. Among patients who started the postoperative phase, 105 (51.0%) received FLOT, while 37 (18%) received de-intensified regimens, depending on clinical condition or previous toxicities. pCR was achieved in 7.3% of cases. Safety profile was consistent with literature. Neutropenia was the most common G 3–4 adverse event (AE): 19.9% in the preoperative phase and 16.9% in the postoperative phase. No toxic death was observed and 30-day postoperative mortality rate was 1.0%. ORR was 45.6% and disease control rate (DCR) was 94.2%. Disease-free survival (DFS) and OS were significantly longer in case of pCR (p = 0.009 and p = 0.023, respectively). A trend towards better DFS was observed among MSI-H patients. Conclusions These real-world data confirm the feasibility of FLOT in an unselected population, representative of the clinical practice. pCR rate was lower than expected, nevertheless we confirm pCR as a predictive parameter of survival. In addition, MSI-H status seems to be a positive prognostic marker also in patients treated with taxane-containing triplets.

Perioperative FLOT in elderly patients with resectable gastric cancer: Subgroup analysis from the observational RealFLOT study.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 4548-4548
Author(s):  
Elisa Giommoni ◽  
Ferdinando De Vita ◽  
Irene Pecora ◽  
Francesco Iachetta ◽  
Antonia Strippoli ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Elderly Patients ◽  
Safety Profile ◽  
Treatment Strategy ◽  
Age Groups ◽  
Disease Free Survival ◽  
Complete Response ◽  
Postoperative Phase ◽  
Real World Data ◽  
Resectable Gastric Cancer

4548 Background: The treatment strategy for patients with resectable gastric cancer changed in the last few years with perioperative treatments. FLOT regimen (fluorouracil, oxaliplatin, docetaxel) turned out to be feasible and effective, offering significant improvement in survival outcomes. However, the safety profile of triplet therapies for elderly patients deserves a special attention and, consequently, the best treatment strategy for these patients is still debated. Methods: Focusing on the elderly patient population (age ≥65 years), real-world data from patients with resectable gastric or gastro-oesophageal junction (GEJ) adenocarcinoma (T≥2 and/or N+) enrolled in the observational RealFLOT study were collected. Results: A total of 206 patients with resectable gastric or GEJ adenocarcinoma received perioperative FLOT at 15 Italian centers in routine clinical practice, between September 2016 and September 2019. The median age was 63 years (range 36-77) and 43% of patients enrolled (n = 89) were ≥65 years. Among elderly patients, 46 (52%) received FLOT for at least 4 full-dose cycles in the preoperative phase, 82 (92%) underwent surgery, and 56 (62%) started the postoperative phase. The primary end point of the study, pathological complete response (pCR) rate, was similar among patients aged ≥65 and < 65 (6.7% vs 7.7%, respectively). The distribution of pathological stages did not differ according to age (p = 0.473), and disease-free survival (DFS) is unrelated to the age of patients (log-rank 0.57; p = 0.89). The incidence of grade (G) 3-4 adverse events (AEs) was similar in the two age groups (Table) and the 30-day mortality rates after surgery did not differ according to age. Conclusions: FLOT regimen demonstrated to be feasible and safe in elderly patients since no differences were observed in terms of pCR, DFS and safety profile according to age. [Table: see text]

scholarly journals Real-world data of thrombotic microangiopathy management: The key role of ADAMTS13 activity and complement testing

2021 ◽  
Vol 3 ◽  
pp. 100043
Author(s):  
Eleni Gavriilaki ◽  
Eudoxia-Evaggelia Koravou ◽  
Thomas Chatziconstantinou ◽  
Christina Kalpadaki ◽  
Nikoleta Printza ◽  
...  
Keyword(s):  
Real World ◽  
Thrombotic Microangiopathy ◽  
Adamts13 Activity ◽  
Real World Data ◽  
World Data

When will it be better? Lenvatinib combined with TACE for unresectable hepatocellular carcinoma: A retrospective analysis of real-world evidence in China.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 281-281
Author(s):  
Lan Zhang ◽  
Yanhong Wang ◽  
Ningling Ge ◽  
Yu-Hong Gan ◽  
ZhengGang Ren ◽  
...  
Keyword(s):  
Combination Treatment ◽  
Real World ◽  
Response Rate ◽  
Objective Response ◽  
Progression Free Survival ◽  
Combination Group ◽  
Optimal Timing ◽  
Real World Data ◽  
Combination Strategy ◽  
Significant Difference

281 Background: TACE and lenvatinib has each shown to prolong overall survival in patients with unresectable HCC, combination of which may also improve clinical outcomes and have been widely used in the real world accordingly. However, the optimal timing of adding on lenvatinb to TACE remains unclear. We are aiming to evaluate the efficacy and safety between two combination strategies. Methods: From Nov 2018 to Jun 2020, 79 consecutive patients had received a combination treatment of lenvatinib and TACE. Patients followed up for more than 2 months were included in this analysis. They were classified as early-combination group(add on lenvatinib before or after the first TACE ) and late-combination group(add on lenvatinib after at least two procedures of TACE ). Tumor response and progression-free survival (PFS,time from the first day of prescribing lenvatinib to progression or death) were assessed according to RECIST1.1 criteria. Liver function were also evaluated at baseline and every 2 months later. AEs were recorded during the combination treatment period according to CTCAE 5.0. Results: A total of 48 u-HCC patients was finally enrolled. Median follow-up in all patients was 9.3(5.3-14.3)months. Patients’ baseline characteristics were similar in two groups. For early-combination group(n=22)and late-combination group(n=26), the mean age was 65±9.7 and 61±11.6years(p=0.2);BCLC stage C HCC was 59% and 54%(p=0.89);and Child-Pugh A proportion was 81.8% and 77%(p=0.73) respectively. The objective response rate(ORR) was 22.9% in total 48 cases. There was no significant difference in response rate (18.2% vs 26.9%, P=0.51) or disease control rate (90.9% vs 92.3%, P=1.00). Median PFS was significantly longer in the early-combination group than that in late-combination group (14.5 vs 8.9 months; p=0.048). The safety profile was similar between two groups. Grade 3/4 adverse events were 3 (13.6%) and 2 cases(7.7%) respectively (P=0.65). Conclusions: This is to date the first real-world data of the combination timing of lenvatinib with TACE in u-HCC patients. Early-combination strategy may be a better option for the u-HCC patients with a longer mPFS.

scholarly journals The Expanding Role of Real-World Evidence Trials in Health Care Decision Making

2019 ◽  
Vol 14 (1) ◽  
pp. 174-179 ◽  
Author(s):  
David C. Klonoff
Keyword(s):  
Real World ◽  
Clinical Evidence ◽  
Real World Data ◽  
Medical Products ◽  
Advantages And Disadvantages ◽  
Randomized Controlled ◽  
Real World Evidence ◽  
Care Decision

Real-world evidence (RWE) is the clinical evidence about benefits or risks of medical products derived from analyzing real world data (RWD), which are data collected through routine clinical practice. This article discusses the advantages and disadvantages of RWE studies, how these studies differ from randomized controlled trials (RCTs), how to overcome barriers to current skepticism about RWE, how FDA is using RWE, how to improve the quality of RWE, and finally the future of RWE trials.

Surgery of colorectal metastasis in the Optimox 1 study. A GERCOR Study

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 3522-3522 ◽  
Author(s):  
N. Perez-Staub ◽  
G. Lledo ◽  
F. Paye ◽  
B. Gayet ◽  
M. Flesch ◽  
...  
Keyword(s):  
Median Overall Survival ◽  
Response Rate ◽  
Disease Free Survival ◽  
Complete Response ◽  
Additional Benefit ◽  
Curative Intent ◽  
Free Survival ◽  
Before And After ◽  
Unresectable Metastasis ◽  
Disease Free

3522 Background: Surgery of metastasis can cure arround 20% of metastatic colorectal cancer (MCRC) patients. The Optimox 1 study achieved a response rate over 50% with FOLFOX therapy in patients (pts) with initially unresectable metastasis which allowed to perform surgery in a significant number of pts (JCO 2006). We report here the results in pts who underwent surgery of metastasis (met). Methods: From jan 2000 to june 2002, 620 previously untreated patients with unresectable metastasis were randomized between FOLFOX4 every two weeks until progression (arm A), or FOLFOX7 for 6 cycles, maintenance without oxaliplatin for 12 cycles and reintroduction of FOLFOX7 (arm B). 101 pts were resected with a curative intent, 57 in arm A and 45 in arm B. Results: Patients characteristics were (arm A/B %): metachronous metastasis 77/51, liver met 82/91, lung met 16/11, other met 7/4, PAL < 3 ULN: 98/97, normal LDH: 52/51. 8% of pts achieved a complete response, 72% a partial response, 16% a stable disease. 89 pts had a single resection, 12 had a two-stage surgery. One patient died in arm B. Eleven pts who relapsed had a second surgery. Resection was radical (R0) for 71 pts (43 in arm A and 28 in arm B), 15 were R1 (margin invasion) and 15 were R2. R0/R1 patients had a median overall survival (OS) of 51 mo in arm A and 38 mo in arm B. Median disease-free survival (DFS) since surgery was 12 mo in arm A and 9 mo in arm B, with no statistical difference. 32% of R0/R1 pts were alive with no progression at 3 years in arm A and 20% in arm B. Median time from randomization to surgery was 8 mo. No difference was found between patients resected before 8 mo (n = 50) and after (n = 37) in OS (39 vs 45 mo, p = .67) nor in DFS (11.6 vs 9.5 mo, p = .24). Neither in pts resected before and after 6 mo in OS (p = .77) and DFS (p = .44). Conclusions: FOLFOX treatment allowed 14 % of unresectable patients to be rescued by surgery. There was no additional benefit to perform surgery after 6 months of therapy compared to early surgery. [Table: see text]

Preoperative chemoradiotherapy (CRT) in gastric cancer.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 89-89
Author(s):  
Anouk Kirsten Trip ◽  
Boelo Jan Poppema ◽  
Mark I. van Berge Henegouwen ◽  
Edwin PM Jansen ◽  
Ester Siemerink ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Response Rate ◽  
Bowel Perforation ◽  
Pathologic Complete Response ◽  
Postoperative Mortality ◽  
Treatment Compliance ◽  
Radical Resection ◽  
Complete Response ◽  
Severe Toxicity ◽  
Grade Iii

89 Background: The prognosis of gastric cancer patients remains poor even after radical surgery. Although local control and survival are significantly improved by postoperative CRT, treatment compliance is frequently compromised due to severe toxicity. On the other hand, treatment compliance is good with preoperative chemotherapy (CT) in gastric cancer and preoperative CRT in esophageal cancer. The current study was initiated to investigate the feasibility and efficacy of preoperative CRT for marginally resectable and initially irresectable gastric cancer. Methods: Patients with marginally resectable and initially irresectable gastric cancer, without signs of peritonitis carcinomatosa, stage IB-IV(M0) were treated with CRT. Treatment consisted of irradiation to a total dose of 45 Gy given in 25 fractions of 1.8 Gy combined with concurrent weekly carboplatin (AUC 2) and paclitaxel (50mg/m2) on days 1, 8, 15, 22 and 29 of irradiation, followed by standardized surgery 4-6 weeks after the last irradiation. Results: Between December 2007 and January 2012, 25 patients with stage II-IV(M0) marginally resectable (n=13) or initially irresectable gastric cancer received preoperative CRT. One patient discontinued concurrent CT in the 4th week due to toxicity, but completed radiotherapy, and another patient stopped CRT after the 3rd week due to progressive disease. During CRT, grade III gastrointestinal adverse events (AE) occurred in 3 patients (12%), grade III hematological AE in 3 (12%) and grade III other AE in 2 (8%). Twenty-four patients (96%) were operated following CRT. Surgery-related complications consisted of anastomotic leakage in 3 patients (12%) and bowel perforation in 2 (8%). Postoperative mortality was 4%. A microscopically radical resection was achieved in 18 patients (72%), 8 of whom had initially irresectable gastric cancer. The pathologic complete response rate was 16% (4/25 patients). Conclusions: In this study, preoperative CRT for marginally resectable and initially irresectable gastric cancer was associated with manageable toxicity and resulted in an encouraging pathologic response rate. A multicenter phase II study has recently been initiated.

Rectal adenocarcinoma: Outcomes of adjuvant chemotherapy after neoajuvant chemoradiotherapy in a retrospective cohort.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 790-790
Author(s):  
Vanessa Pachón Olmos ◽  
Pablo Reguera Puertas ◽  
Reyes Ferreiro Monteagudo ◽  
FEDERICO LONGO ◽  
Mercedes Rodríguez Garrote ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Adjuvant Chemotherapy ◽  
Rectal Adenocarcinoma ◽  
Disease Free Survival ◽  
Complete Response ◽  
Local Relapse ◽  
Stage Ii ◽  
Systemic Relapse ◽  
The Impact

790 Background: The role of adjuvant chemotherapy (AC) after chemoradiotherapy and surgery in stage II and III of rectal cancer is not well defined. Neither the regimen nor the duration is clear. Besides, guidelines from different expert groups are conflicting. Methods: 224 patients diagnosed from January 2003 to December 2013 with rectal adenocarcinoma T3/T4 and/or positive node staged by ultrasound or magnetic resonance imaging was collected retrospectively from the Pathology Department data base. Results: Of the 224 patients 61.6% were male, median of age at diagnosis 68.6 years (range 31.3-85.4). All of them received 50.4 Gy with different concomitant regimens (capecitabine, continuous infusion of fluoracil or bolus of fluoracil-leucovorin). 13.4% of patients achieved a pathological complete response. 76.8% of the cohort received adjuvant chemotherapy. The main reasons for not receiving chemotherapy were ECOG ≥ 2, surgery complications and a decision of the patient. 51.2% of patients received an oxaliplatin based regimen and the median time of chemotherapy duration was 4 months (range 1-6 months). Local relapse was diagnosed in 6.3% of patients while a systemic relapse was found in 22.3%. Patients without AC had a mean overall survival (OS) of 85.5 months (CI 95% 70.7-100.4) versus 119.8 monts (CI 95% 110.8-128.8) in the AC cohort (p 0.002) without reaching the median after 58 months (range 8-153.9) median follow-up. Disease free survival (DFS) was also better in the AC cohort with a mean DFS of 104 months (CI 95% 94.3-113.6) versus 71.4 months (CI 95% 55.4-87.4), p = 0.01. Conclusions: AC after chemoradiotherapy and surgery in stage II and III rectal cancer as a standard does not exist. In our cohort, AC showed a significant improve in OS and DFS, but the limitations of a retrospective study should be considered, as well as the impact of surgery on metastasis and salvage chemotherapies. Randomized studies are clearly needed.

Checkpoint inhibitor (CPI) experienced patients (pts) from COSMUS-1: A clinical observational study of talimogene laherparepvec (T-VEC) in United States practice.

2019 ◽  
Vol 37 (8_suppl) ◽  
pp. 142-142 ◽  
Author(s):  
Matthew Perez ◽  
Thomas Amatruda ◽  
Robert Martin Conry ◽  
Charlotte Eielson Ariyan ◽  
Anupam M. Desai ◽  
...  
Keyword(s):  
Adverse Events ◽  
Real World ◽  
Pathologic Complete Response ◽  
Complete Response ◽  
Real World Data ◽  
Clinicopathologic Characteristics ◽  
Immune Mediated ◽  
Group A ◽  
Previously Treated ◽  
Group B

142 Background: T-VEC, a modified oncolytic herpes virus, is an intralesional therapy for unresectable advanced melanoma. COSMUS-1, a recently presented observational chart review study from 7 US academic sites, described metastatic melanoma treatment (tx) patterns and safety of T-VEC in the real-world setting (Perez et al, SMR 2018). In this analysis, we evaluated T-VEC use in pts after prior CPI use or with CPI from COSMUS-1. Methods: Of 76 pts treated with T-VEC (first dose 27Nov2015-15Dec2016), 33 pts had received pembrolizumab, nivolumab and/or ipilimumab (ie, CPI) prior to or with T-VEC and were analyzed for demographics, clinicopathologic characteristics, outcomes, and adverse events. Two groups were identified: Group A, CPI then T-VEC only and Group B, CPI with T-VEC. Results: There were 21 pts in A and 12 pts in B; in B, all received TVEC + CPI with (1) prior CPI, n = 5, (2) prior CPI and additional CPI after combination, n = 1, (3) as combination only, n = 4, or (4) as combination followed by CPI only, n = 2. In A and B, respectively, mean age was 72 yrs and 63 yrs; 12 (57%) and 9 (75%) were men; 17 (81%) and 9 (75%) had ECOG 0-1,10 (48%) and 4 (33%) had Stage IIIB-IVM1a, and 11 (52%) and 7 (58%) had Stage IVM1b/c. Two pts (both in B) remained on T-VEC by study end. 21 (100%) pts in A and 10 (83%) pts in B discontinued T-VEC (most common, respectively: 10 pts and 3 pts due to disease progression, 4 pts and 2 pts due to physician decision). 2 pts had no injectable lesions left (in A) and 1 pt (in A) had pathologic complete response (CR). Adverse events of interest were reported in 7 pts (33%) in A and 6 pts (50%) in B; most common events in A and B, respectively, were immune-mediated events (n = 3 and 6) which included flu-like symptoms (fever, chills, rigor; n = 2 and 5) and injection site complications (n = 5 and 2). No herpetic infections were reported in pts. Conclusions: These real-world data suggest that T-VEC is well tolerated and can be administered in pts previously treated with a CPI, both those who switched to T-VEC or those where T-VEC was added on. One pt achieved a pathologic CR.

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