Perioperative FLOT in resectable gastric cancer: Italian real-world data from the RealFLOT study.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 300-300
Author(s):  
Elisa Giommoni ◽  
Ferdinando De Vita ◽  
Irene Pecora ◽  
Francesco Iachetta ◽  
Antonia Strippoli ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Clinical Practice ◽  
Performance Status ◽  
Safety Data ◽  
Final Analysis ◽  
Real Data ◽  
Complete Response ◽  
Postoperative Phase ◽  
Real World Data ◽  
Resectable Gastric Cancer

300 Background: Perioperative treatments have significantly improved survival in patients with resectable gastric cancer, increasing 5-year overall survival from 23% with surgery alone to 45% with FLOT (fluorouracil, oxaliplatin, docetaxel). Pathological regression is a prognostic marker of better survival. Methods: In this observational, retro- and prospective study we collected data from patients with resectable gastric or gastro-oesophageal junction (GEJ) adenocarcinoma treated, as clinical practice, with perioperative FLOT. All patients had clinical T2 or higher and/or nodal involvement, according to FLOT4-AIO trial. Results: A total of 206 patients received perioperative chemotherapy with FLOT at 15 Italian centres, between September 2016 and September 2019. Overall, 186 (90.3%) patients completed the preoperative phase, 190 (92%) 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 less intensive regimens (e.g. FOLFOX or De Gramont), depending on performance status after surgery or toxicity in the preoperative phase. Pathological complete response (pCR) was obtained in 7.3% of cases. In the preoperative phase, grade (G) 3-4 hematological and gastrointestinal adverse events (AEs) were reported in 42 (20.4%) and 13 (6.3%) patients, respectively. Conclusions: These real data confirmed the feasibility of perioperative FLOT in a less-selected population, representative of the clinical practice. The pCR rate was lower than in the FLOT4-AIO trial. The survival outcomes, potential predictive or prognostic factors and comprehensive safety data will be included in the final analysis. [Table: see text]

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]

Retrospective analysis of sorafenib as first or second target therapy in mRCC patients in Italian centers: An update.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e15524-e15524
Author(s):  
Lisa Derosa ◽  
Angela Gernone ◽  
Franco Morelli ◽  
Teodoro Sava ◽  
Fable Zustovich ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Retrospective Analysis ◽  
Target Therapy ◽  
Performance Status ◽  
Single Agent ◽  
Progression Free Survival ◽  
Complete Response ◽  
Daily Clinical Practice ◽  
Duration Of Treatment ◽  
Ecog Performance Status

e15524 Background: With several agents available for the treatment of metastatic renal cell carcinoma (mRCC) a better understanding of their use in daily clinical practice is fundamental in the decision-making process. Methods: The REtrospective analysis of Sorafenib (So) as 1st or 2nd targET therapy (RESET) in mRCC was a retrospective, observational field study that assessed the use and safety of So in clinical practice in Italian centers. Treatments were determined by physicians per local prescribing guidelines. Patients (pts) treated with So single agent as 1st or 2nd target therapy (TT) for mRCC between 1st Jan 2008 and 31st Dec 2010 were eligible for inclusion. Endpoints included safety, overall survival (OS), progression-free survival, response rate and treatment duration. Subgroup analyses included age, ECOG performance status, prior therapy, number of metastases and line of TT with So. Results: From Feb to Jul 2012, 358 pts from 37 Italian centers were enrolled. The most common ≥ grade 3 drug-related adverse events were hand-foot skin reaction (6.7%), rash (2.2%), hypertension, fatigue and diarrhea (1.7% each). In the overall population, median OS was 17.2 months (mos) (95% CI 15.4 – 19.6 mos) and median PFS was 5.9 mos (95% CI 4.9-6.7 mos). Median duration of treatment with So was 5.03 mos. Disease control (complete response + partial response + stable disease) was observed in 198(56%) pts. In pts receiving So as first or as second TT median OS was 19.9 mos (95% CI 15.9-25.3 mos) and 16.3 mos (95% CI 13.0-18.2 mos) respectively. In the subgroup of pts treated with So 1st TT followed by sunitinib (Su) 2nd TT (44 pts) and Su 1st TT followed by So 2nd TT (173 pts), median OS was 30.4 mos (95% CI 22.0-34.8 mos) and 16.6 mos (95% CI 13.1-18.2 mos) respectively. There were 269(76%) pts that received a total of 2 lines of therapy for mRCC, 133(38%) pts 3 lines and 43(12%) pts 4 lines of therapy. Conclusions: The efficacy and safety profile of So in the setting of Italian community-based daily clinical practice was similar to data reported in prospective clinical trials. The efficacy of So was observed in both the subgroups of pts receiving So as either the first or second TT for mRCC, with intriguing OS data in first line.

Phase III Randomized Controlled Trial Comparing the Survival of Patients With Unresectable Hepatocellular Carcinoma Treated With Nolatrexed or Doxorubicin

2007 ◽  
Vol 25 (21) ◽  
pp. 3069-3075 ◽  
Author(s):  
Robert G. Gish ◽  
Camillo Porta ◽  
Lucian Lazar ◽  
Paul Ruff ◽  
Ronald Feld ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Karnofsky Performance Status ◽  
Controlled Trial ◽  
Performance Status ◽  
Objective Response ◽  
Progression Free Survival ◽  
Final Analysis ◽  
Complete Response ◽  
Phase Iii ◽  
Study Objective

PurposeThe study objective was to compare the overall survival (OS) of patients with unresectable or metastatic hepatocellular carcinoma (HCC) treated with nolatrexed (NOL) or doxorubicin (DOX).Patients and MethodsPatients from North America, Europe, and South Africa (N = 445) with HCC were randomly assigned to receive NOL or DOX. Eligible patients had Karnofsky performance status (KPS) ≥ 60%, Cancer of the Liver Italian Program (CLIP) score ≤ 3, and adequate organ function. Primary end point was OS. Secondary end points included progression-free survival (PFS), objective response rates, and safety. The treatment groups were well-balanced with regards to age, sex, ethnic origin, and underlying liver disease. Randomization was stratified according to KPS and CLIP score.ResultsAt the time of the final analysis, 377 patients had died. Median OS was 22.3 weeks for NOL and 32.3 weeks for DOX (P = .0068). The hazard ratio was 0.753 in favor of DOX. Objective response rate (complete response [CR] plus partial response [PR]) was 1.4% for NOL and 4.0% for DOX. Median PFS was 12 weeks for NOL and 10 weeks for DOX (P = .7091). Median time to treatment failure was 8.4 weeks for NOL and 9.1 weeks for DOX (P = .0969). Grade 3 and 4 stomatitis, vomiting, diarrhea, and thrombocytopenia were more common in the NOL arm. Alopecia was more common in the DOX arm. More patients were withdrawn from study for toxicity in the NOL arm than in the DOX arm.ConclusionNOL showed minimal activity in this phase III trial. Further exploration at this dose and schedule in HCC is not warranted.

Phase I-II trial of daily thalidomide in combination with docetaxel in patients with relapsed non-small cell lung cancer: A final analysis

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 17060-17060
Author(s):  
C. W. Seidler ◽  
E. Scepansky ◽  
S. Khanani ◽  
J. Rooney ◽  
J. Gordon ◽  
...  
Keyword(s):  
Disease Progression ◽  
Response Rate ◽  
Performance Status ◽  
Final Analysis ◽  
Complete Response ◽  
Hepatic Function ◽  
Median Number ◽  
Second Line ◽  
Ecog Performance Status ◽  
Prior Chemotherapy

17060 Background: Recent studies have shown that inhibition of vascular endothelium growth factor (VEGF) in combination with chemotherapy can improve the antitumor efficacy of chemotherapy in NSCLC. This study tested the effectivness and toxicity of thalidomide (an inhibitor of VEGF) combined with docetaxel as second-line therapy for progressive NSCLC. Methods: Patients(pts) with recurrent/progressive NSCLC, prior chemotherapy, measurable/evaluable disease, ECOG performance status (PS) 0–2 and adequate hematologic, renal and hepatic function were enrolled. Pts with uncontrolled CNS disease or hypercoagulable state were excluded. Doxetaxel 75 mg/M2 was administered every 3 weeks (maximum of 8 cycles). Thalidomide was administered orally at a starting dose of 50 mg daily escalated by 50 mg every 3 weeks to a maximum dose of 200mg day and continued until disease progression, dose limiting toxicity, or completion of chemotherapy. Primary end-point was overall survival (OS), secondary end points were time to disease progression(TTP) by Kaplan Meyer method and response rate (RECIST criteria). Results: Of 28 enrolled patients, 26 were eligible for treatment and 25 were evaluable for disease progression and survival. For evaluable pts: mean PS = 1, median age 64.5 years, median number of prior chemotherapy regimens + 1.2. Response rate was 19.1% (1 complete response, 4 partial responses). Stable disease was observed in 9 patients (34.6%). TTP was 2.7 months (95% confidence interval [CI] 2.1–5.0+): median OS was 5.4 months (95% CI 3.1–9.3+). One episode each of febrile neutropenia requiring hospitalization and pulmonary embolism was observed. No grade 3–4 neuropathy was shown. Nonhematologic adverse events included constipation, alopecia, nausea and anorexia. Conclusions: These data suggest thalidomide in doses of 200mg/ day may be combined with docetaxel 75 mg/m2 every 3 weeks in the second line treatment of NSCLC. The response rate, TTP and OS compare favorably with previously reported studies with docetaxel in this population. No significant financial relationships to disclose.

Neoadjuvant chemoradiation for potentially resectable gastric cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e14724-e14724
Author(s):  
Michael E. Barfield ◽  
Brian R. Untch ◽  
Justin T. Arcury ◽  
Brian G. Czito ◽  
Christopher Willett ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Metastatic Disease ◽  
Disease Free Survival ◽  
Complete Response ◽  
External Beam Radiation ◽  
Cross Sectional ◽  
Beam Radiation ◽  
Resectable Disease ◽  
Platinum Based Chemotherapy ◽  
Resectable Gastric Cancer

e14724 Background: Outcomes are poor in patients with gastric cancer, and recurrence is common. Perioperative chemotherapy and adjuvant chemoradiation therapy (CRT) improve survival in patients with resectable disease. Experience with neoadjuvant CRT for potentially resectable disease is limited, and its role remains undefined. We report our experience using neoadjuvant CRT for potentially resectable gastric cancer. Methods: An IRB-approved, retrospective review from 1994 to 2007 identified 23 patients with biopsy-proven, potentially resectable gastric cancer. Patients had T2/T3 and/or N1 disease and no evidence of metastatic disease by endoscopic ultrasound and cross-sectional imaging. All underwent neoadjuvant external beam radiation with concurrent 5-FU or platinum-based chemotherapy followed by restaging and surgery if appropriate. Results: Of the 23 patients, 20 completed neoadjuvant CRT and surgical exploration. Two patients (n=2) had radiographic disease progression during neoadjuvant CRT and did not undergo resection. One patient (n=1) developed a perforated gastric ulcer during CRT and underwent emergent resection. The median time from diagnosis to surgery and completion of neoadjuvant CRT to surgery was 104 days and 37.5 days, respectively. Gastrectomy was performed in 17 (85%) patients who completed neoadjuvant CRT. Metastatic disease was identified in the remaining 3 (15%) patients. Following gastrectomy, a complete pathologic response was observed in 4 (23.5%) patients, a partial response in 11 (64.7%) patients, and no response was identified in 2 (11.8%) patients. One (6%) patient had microscopic positive margins, and 9 (53%) had positive lymph nodes. There was no perioperative mortality. Two (11.8%) patients had anastomotic leaks, which were managed non-operatively. The median length of stay was 10 days. The median disease-free survival was 10.5 months, and median overall survival was 19.6 months. Conclusions: Gastric cancer carries a poor prognosis. Surgical resection after neoadjuvant CRT has low treatment-associated morbidity and mortality. Survival and complete response rates are comparable to published series. Further evaluation of this treatment strategy is warranted to assess its efficacy.

Perioperative chemotherapy versus adjuvant chemoradiation in resectable gastric cancer: A national cancer database analysis.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 7066-7066
Author(s):  
Sindhu Janarthanam Malapati ◽  
Sunny R K Singh ◽  
Rohit Kumar ◽  
Ahmed Abdalla ◽  
Tarik H. Hadid
Keyword(s):  
Gastric Cancer ◽  
Surgical Resection ◽  
Randomized Clinical Trials ◽  
Cox Regression ◽  
Tumor Resection ◽  
Postoperative Mortality ◽  
Adjuvant Chemoradiotherapy ◽  
Perioperative Chemotherapy ◽  
Real World Data ◽  
Resectable Gastric Cancer

7066 Background: In patients with resectable gastric cancer, the use of either perioperative chemotherapy (POC) or adjuvant chemoradiotherapy (CRT) are acceptable treatment options in addition to surgical resection. Both approaches improved overall survival (OS) compared to surgery alone. Randomized controlled trials comparing these two modalities are lacking. This study uses real-world data to compare the clinical outcomes of these two approaches. Methods: We identified gastric cancer patients in the NCDB who had definitive surgery between years 2004 and 2015. They were divided into two cohorts: POC and adjuvant CRT. We compared the OS and surgical outcomes in both groups. Kaplan-Meier method and multivariable Cox regression model were used to estimate survival. Results: Of 75,654 patients who underwent definitive surgical resection, 1,920 had POC and 9,161 had adjuvant CRT. Median OS was 56 months with POC and 38.5 months with CRT. After adjusting for age, gender, race, insurance status, comorbidity index, and treatment facility, patients who received POC had an 18% reduction in all-cause mortality compared to those who received adjuvant CRT (p <0.0001, 95% confidence interval 0.74- 0.88). Although, 30- and 90-day mortality was slightly higher with POC compared to CRT (0.047 vs. 0.03%, p<0.0001 and 1.46 vs. 0.45%, p<0.0001 for 30 and 90 day mortality, respectively). Length of hospital stay for primary tumor resection was similar between the two groups; but the 30 day readmission rate after surgery was higher with CRT compared to POC (12.74 vs. 8.33%, p<0.0001). Conclusions: Among patients undergoing definitive surgical resection for gastric cancer, our study shows an association between the use of POC (vs. adjuvant CRT) and improvement in OS. In the POC cohort, while there was a slight increase in postoperative mortality, this was surpassed by the benefit derived from use of POC, resulting in net improvement of survival. These interesting observations warrant confirmation in randomized clinical trials. [Table: see text]

scholarly journals Importance of HER2 Work-Up and Treatment Even in Patients with Poor Performance Status: A Case Report

2014 ◽  
Vol 2014 ◽  
pp. 1-4
Author(s):  
Ali Suner ◽  
Hakan Buyukhatipoglu ◽  
Ozan Balakan ◽  
Mehmet Emin Kalender ◽  
Turgay Ulas ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Performance Status ◽  
Poor Performance ◽  
Complete Response ◽  
Metastatic Gastric Cancer ◽  
Poor Performance Status ◽  
Her2 Overexpression ◽  
First Line ◽  
Work Up

Gastric cancer is one of most common types of cancers. Metastatic gastric cancer has a poor prognosis and is accepted as incurable at this stage. Treatment of metastatic gastric cancer did not progress substantially until new targeted agents have come out. Recently published ToGA trial showed promising results in HER2 overexpressing metastatic gastric cancer. In this case we present a case with an excellent complete response with anti-HER2 treatment. Most importantly, we wanted to emphasize (1) the importance of early determination of HER2 overexpression, and (2) to draw attention of anti-HER2 agents in the first line treatment even in patients with a poor performance status.

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.

scholarly journals Pseudocirrhosis in Gastric Cancer with Diffuse Liver Metastases after a Dramatic Response to Chemotherapy

2016 ◽  
Vol 9 (1) ◽  
pp. 106-111 ◽  
Author(s):  
Seiichiro Mitani ◽  
Shigenori Kadowaki ◽  
Hiroya Taniguchi ◽  
Hisanori Muto ◽  
Kei Muro
Keyword(s):  
Gastric Cancer ◽  
Liver Metastases ◽  
Group Performance ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Oral Intake ◽  
Complete Response ◽  
Metastatic Gastric Cancer ◽  
Response To Chemotherapy ◽  
Multiple Liver Metastases

We present the first reported case of pseudocirrhosis arising after a dramatic response to chemotherapy in metastatic gastric cancer. A 74-year-old man was diagnosed with gastric adenocarcinoma having multiple liver metastases. His general condition was poor, with an Eastern Cooperative Oncology Group performance status of 3, inadequate oral intake, and jaundice (total bilirubin 2.8 mg/dl). Chemotherapy with oxaliplatin, L-leucovorin, and 5-fluorouracil (modified FOLFOX-6) was initiated. After four treatment cycles, he experienced a marked regression of liver metastases; however, he developed massive ascites with a lobular liver surface and segmental atrophy, which were consistent with pseudocirrhosis. Chemotherapy was continued along with ascites management. Thereafter, ascites disappeared, and a complete response of the metastatic lesions was achieved at 11 months after initial treatment. He had no evidence of disease progression at 30 months after initial chemotherapy. This report suggests clinicians should recognize this entity, even in gastric cancer metastatic to the liver.

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