Preoperative docetaxel, cisplatin, and 5-fluorouracil for resectable esophagogastric junction adenocarcinoma: A retrospective study.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 209-209
Author(s):  
Toshiharu Hirose ◽  
Shun Yamamoto ◽  
Kotoe Oshima ◽  
Hidekazu Hirano ◽  
Natsuko Okita Tsuda ◽  
...  
Keyword(s):  
Retrospective Study ◽  
Adverse Events ◽  
Preoperative Chemotherapy ◽  
Esophagogastric Junction ◽  
Clinical Stage ◽  
Progression Free Survival ◽  
Completion Rate ◽  
R0 Resection ◽  
Histological Response ◽  
Esophagogastric Junction Adenocarcinoma

209 Background: In Western countries, 5-FU plus leucovorin, oxaliplatin, docetaxel (DTX) (FLOT) is the standard perioperative treatment for resectable gastric adenocarcinoma and esophagogastric junction adenocarcinoma (EGJ-AC). Preoperative chemotherapy with DTX plus cisplatin and 5-FU (DCF) has been developed for esophageal squamous cell carcinoma in Japan. However, there have been few reports on the safety and efficacy of preoperative triple therapy for resectable EGJ-AC. Methods: The subjects of this retrospective study were patients (pts) with histologically confirmed resectable EGJ-AC who received preoperative DCF chemotherapy (DTX 70 mg/㎡ and cisplatin 70 mg/㎡ on day 1, and continuous infusion of 5-FU 750 mg/㎡/day on days 1–5, every 3 weeks with a maximum of three cycles) at our hospital from Jan 2015 to Apr 2020. We evaluated the completion rate of >2 courses of DCF and R0 resection in all cases, and also examined histological response, progression-free survival (PFS), overall survival (OS), and adverse events during preoperative chemotherapy. Results: Thirty-two pts were included in this study, and the median observation period was 13.1 months (3.9–57.2). Characteristics were median age (range) 63 (42–80) years, PS 0/1 66/34%, clinical stage I/IIA/IIB/III/IVA/IVB (supraclavicular lymph node) 3/13/3/10/22/32/13%. Treatment completion rate was 84%. Histological response (grade 1a/1b/2/3) was obtained in 18/8/4/1 (58/26/13/3%) pts. Median PFS (95%CI) was 16.8 months (15.0–18.5), and median OS was not reached (3-year OS rate 73.8%). Grade >3 adverse events were observed in 20(63%) pts (neutropenia in 14 [44%], febrile neutropenia in 4 [13%]). No treatment-related deaths occurred. Conclusions: Preoperative DCF chemotherapy for resectable EGJ-AC was well tolerated. Further investigation is required to evaluate the long-term efficacy of this treatment strategy.

FRONTiER: A feasibility trial of nivolumab with neoadjuvant CF or DCF therapy for locally advanced esophageal carcinoma (JCOG1804E)—The short-term results of cohort A and B.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 202-202
Author(s):  
Shun Yamamoto ◽  
Ken Kato ◽  
Hiroyuki Daiko ◽  
Takashi Kojima ◽  
Hiroki Hara ◽  
...  
Keyword(s):  
Adverse Events ◽  
Checkpoint Inhibitors ◽  
Tnm Classification ◽  
Clinical Stage ◽  
Cell Cancer ◽  
Locally Advanced ◽  
Cytotoxic Agents ◽  
Feasibility Trial ◽  
R0 Resection ◽  
Breast Cancers

202 Background: The standard neoadjuvant chemotherapy (NAC) in Japan for locally advanced esophageal squamous cell cancer (ESCC) is CDDP + 5-FU (CF). Immune checkpoint inhibitors (ICI) such as nivolumab provide a survival benefit in ESCC, and have potential as NAC agents in lung, skin, and breast cancers, amongst others. However, whether ICI are efficacious in combination with cytotoxic agents, and whether ICI impact the safety of subsequent surgery after they are used as NAC for ESCC patients (pts) is currently unclear. Methods: FRONTiER is a multi-cohort phase I study designed to evaluate the safety and efficacy of ICI combined with NAC in ESCC. Histologically proven ESCC pts with cT1N1-3M0 or cT2-3N0-3M0 (8th-UICC TNM classification), 20–75 years old, PS ≤ 1, no prior therapies against any cancer were eligible. The primary endpoint was the incidence of dose-limiting toxicities (DLT) from the initial dose to the 30th postoperative day. This study contained 4 experimental cohorts, the NAC regimen of cohort A consisted of 2 courses of CDDP at 80 mg/m2, nivolumab at 360 mg/body on day 1 and 5-FU at 800 mg/m2 on days 1–5, q3wks. The regimen of cohort B consisted of one administration of nivolumab at 240 mg/body 2 weeks before chemotherapy, followed by the same treatments as cohort A. Results: Thirteen pts were enrolled to cohort A (n = 6) and B (n = 7). Characteristics were follows; median age: 62 (range: 34–75), PS 0/1: 9/4 pts, clinical stage I/II/III: 2/1/10 pts. One pt in cohort B was excluded from safety evaluation due to R2 resection, no DLTs were observed in 12 pts. The most frequent adverse events (≥ grade 3) were neutropenia in 6 pts during NAC, lung infection in 1, hyperglycemia in 1, pleural effusion in 1, infection (right neck) in 1, anemia in 1, abdominal pain in 1, and anatomic leakage in 1 during the postoperative period. Within 30 days post-operation, grade 2 adrenal insufficiency was observed in 1 pt of cohort B. No grade 4 adverse events or treatment-related deaths were seen. All pts received two courses of NAC + nivolumab and R0 resection was achieved in 12 pts (92.3%) without interruption of treatment. A pathological complete response was achieved in 2 pts (33.3%) in cohort A. Conclusions: Neoadjuvant CF + nivolumab with/without prior administration of nivolumab followed by surgery for locally advanced ESCC was well tolerated and showed promising efficacy. Clinical trial information: NCT03914443.

NEOHX study: Perioperative treatment with trastuzumab in combination with capecitabine and oxaliplatin (XELOX-T) in patients with HER-2 resectable stomach or esophagogastric junction (EGJ) adenocarcinoma—18 m DFS analysis.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 107-107 ◽  
Author(s):  
Fernando Rivera ◽  
Paula Jiménez-Fonseca ◽  
Pilar Garcia Alfonso ◽  
Javier Gallego ◽  
M. Luisa Limon ◽  
...  
Keyword(s):  
Esophagogastric Junction ◽  
Metastatic Gastric Cancer ◽  
R0 Resection ◽  
Preoperative Treatment ◽  
Open Label ◽  
R1 Resection ◽  
Esophagogastric Junction Adenocarcinoma ◽  
Biomarker Analysis ◽  
Open Label Phase ◽  
Her 2

107 Background: Perioperative chemotherapy has demonstrated better OS and DFS than surgery alone in resectable stomach or EGJ adenocarcinoma. Trastuzumab has improved OS when added to chemotherapy in pts with HER-2 + metastatic gastric cancer and is interesting to explore its role in the perioperative setting. Methods: A Spanish, multicenter, open-label phase II study evaluated the efficacy and toxicity profile of perioperative XELOX-T (Capecitabine 1000 mg/m2/12h po days 1-14, oxaliplatin 130 mg/m2 day 1, trastuzumab 8 mg/kgà6 mg/kg day 1, q3w ; 3 preoperative cycles and 3 postsurgery cycles followed by 12 cycles of trastuzumab monotherapy) in patients with T1-2N+M0 or T3-4NxM0 resectable stomach or EGJ adenocarcinoma, HER-2+ ( IHQ3+ or IHQ2+/FISH+). The primary endpoint was 18 months DFS, secondary endpoint included pCR, R0 resection rate, ORR, toxicity of preoperative treatment (NCI CTC v3.0 criteria) and biomarker analysis. Results: From June 2010 to March 2012, 36 pts were included: median age 65 (39-85); ECOG 0/1/2: 16/19/1 pts; localization: stomach 21 pts, EGJ 15 pts; histologic type: intestinal: 23 pts, diffuse: 4 pts, mixed: 1pt, not specified 8 pts; TNM: T 4: 7 pts; N+: 31 pts. Preoperative XELOX-T: Response: PR: 14 pts (39%), SD: 18 pts, PD: 0 pts, NE: 4 pts. Surgery was performed in 31 pts: R0: 28 pts (78%, 95% CI: 61-90%), R1: 1 pt, R2: 2 pts (1 had peritoneal carcinomatosis); pCR was observed in 3 pts (8.3 %; 95% CI: 2-22%). Two pts died due to surgical complications. After R0/R1 resection, postoperative XELOX-T was administered to 24 patients, 22 of whom underwent T monotherapy. G3-4 toxicity (>5% of pts): diarrhea 33%, nauseas and vomiting 8% and pneumonia, anemia, neutropenia, anorexia, asthenia and pleural effusion with pneumothorax: 5.5%. With a median follow up of 24.1 months, 18m DFS is 71% (95% CI: 53-83%), 24 m DFS is 60% and median DFS and OS has not been reached. Conclusions: These data suggest that perioperative XELOX+T in HER-2 positive resectable stomach or esophagogastric junction adenocarcinoma is feasible and has promising activity. Clinical trial information: NCT01130337.

Safety results of a phase III randomized trial of comparison of three paclitaxel-based regimens concurrent with radiotherapy for patients with local advanced esophageal squamous cell carcinoma (ESO-Shanghai 2).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 4055-4055
Author(s):  
Dashan Ai ◽  
Yun Chen ◽  
Qi Liu ◽  
Xiangpeng Zheng ◽  
Yunhai Li ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Adverse Events ◽  
Esophageal Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Squamous Cell ◽  
Clinical Stage ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Consolidation Chemotherapy ◽  
Grade 3

4055 Background: Paclitaxel (PTX) is effective in concurrent chemoradiation (CCR) against esophageal squamous cell carcinoma (ESCC) . Which regimen, among cisplatin (DDP) (TP), carboplatin (CBP) (TC) or 5-Fu (TF) in combination with PTX concurrent with radiotherapy, provides best prognosis with minimum adverse events (AEs) is still unknown. Methods: The study compared two pairs of regimens: TF vs. TP and TF vs. TC concurrent with radiotherapy. Patients with histologically confirmed ESCC (clinical stage II, III or IVa) were randomized into the three groups. Patients in TP group were treated with 2 cycles of CCR followed by 2 cycles of consolidation chemotherapy with TP (DDP 25 mg/m2/d, d1-3, PTX 175 mg/m2, d1, q28d). Patients in TF group were treated with 6 cycles of TF (5-Fu 300 mg/m2, civ 96h, PTX 50 mg/m2, d1, qw) in CCR followed by 2 cycles of TF (5-FU 1800 mg/m2, civ 72h, PTX 175 mg/m2, d1, q28d) in consolidation chemotherapy. Patients in TC group were treated with 6 cycles of TC (CBP AUC = 2, d1, PTX 50 mg/m2, d1, qw) in CCR followed by 2 cycles of TC (CBP AUC = 5, d1, PTX 175 mg/m2 d1, q28d) in consolidation chemotherapy. The radiotherapy dose in all groups was 61.2 Gy delivered in 34 fractions. The primary endpoint was overall survival and the secondary endpoints were progression-free survival and adverse events. Results: Between July 2015 and January 2018, 321 ESCC patients in 11 centers were enrolled. TP group had a significant higher incidence of acute grade 3/4 neutropenia (59.7% vs. 16.8%(TF) or 32.4%(TC)), thrombocytopenia (12.7% vs. 3.5%(TF) or 6.2%(TC)), anemia (6.4% vs. 4.4%(TF) or 4.4%(TC)), fatigue (10.0% vs. 0.9%(TF) or 0.9%(TC)) and vomiting (5.5% vs. 0%(TF) or 0.9%(TC)) than other two groups ( P < 0.05). TF group had a significant higher incidence of grade 3/4/5 esophagitis (13.1% vs. 1.8%(TP) or 5.3%(TC)) and pneumonitis (4.4% vs. 0%(TP) or 1.8%(TC)) than other two groups ( P < 0.05). One patient in TF group died of acute pneumonitis. One patient in TF group and one in TC group died of acute esophagitis. Conclusions: TP and TF regimen showed different severe AEs in CCR in ESCC patients and TC showed mild AEs. Clinical trial information: NCT02459457.

Survival and prognostic factors in patients with epithelial ovarian cancer receiving paclitaxel and carboplatin as first-line chemotherapy in Japanese women: A multi-center retrospective study

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 15022-15022
Author(s):  
H. Kajiyama ◽  
F. Kikkawa ◽  
M. Kawai ◽  
K. Mizuno ◽  
I. Kobayashi ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Prognostic Factors ◽  
Retrospective Study ◽  
Epithelial Ovarian Cancer ◽  
Clear Cell ◽  
Histological Grade ◽  
Clinical Stage ◽  
Progression Free Survival ◽  
Figo Stage ◽  
Second Line

15022 Background: The aim of this retrospective study was to re-evaluate, multi-analytically, survival and prognostic factors of patients with epithelial ovarian cancer (EOC) receiving the combination of paclitaxel and carboplatin (PC). Methods: Between 1/00 and 12/04, a total of 335 cases with EOC of FIGO stage I-IV are registered in a multi-institutional series. All patients received cytoreductive surgery and combination chemotherapy of paclitaxel 180 mg/m2/3 hr and carboplatiion AUC = 5 for a total of 6 cycles. We retrospectively analyzed progression-free survival (PFS) and overall survival (OS) of these patients by stratification of assumable several prognostic factors and second-line regimen. Survival probabilities were estimated by Kaplan-Meier methods, and prognostic factors for survival were evaluated by a COX proportional hazard model. Results: Median age was 54 ± 11 years (range 9–81). The 3-, 4- and 5-year OS in patients was 67.0%, 53.9% and 50.6%, respectively. In a COX analysis, FIGO stage, histological type and residual tumor (2 cm < vs. 2 cm >; P = 0.0007, HR; 2.4, 95% CI = 1.4–4.0) were found to be independent significant factors for OS. The stratification analysis revealed that stage III-IV patients with clear cell and mucinous carcinoma have poorer prognosis than those with other histological types ( Table ). In contrast, no differences in histological grade (G1 vs. G2; P = 0.82, HR; 0.9, 95% CI = 0.5–1.6, G1 vs. G3; P = 0.65, HR; 0.9, 95% CI = 0.4–1.6) and kinds of second-line regimen were noticed for PFS and OS. Conclusions: Optimal surgical debulking, clinical stage, and histology appear to be important prognostic factors of survival in patients with EOC. This retrospective study suggests that PC may still have an impact on outcome. However, further strategy will be needed for improving survival of mucinous and clear-cell type EOC, especially with advanced stage. [Table: see text] No significant financial relationships to disclose.

PS02.105: LONG-TERM RESULTS OF PREOPERATIVE CHEMOTHERAPY WITH DOCETAXEL, CISPLATIN AND FLUOROURACIL IN PATIENTS WITH ADVANCED ESOPHAGEAL CARCINOMA

2018 ◽  
Vol 31 (Supplement_1) ◽  
pp. 150-151
Author(s):  
Takashi Ui ◽  
Hirofumi Fujii ◽  
Yoshinori Hosoya ◽  
Alan Lefor ◽  
Hiroyuki Yamaguchi ◽  
...  
Keyword(s):  
Esophageal Carcinoma ◽  
Preoperative Chemotherapy ◽  
Conflicts Of Interest ◽  
Cell Cancer ◽  
Progression Free Survival ◽  
Distant Metastases ◽  
Long Term Results ◽  
R0 Resection ◽  
Curative Surgery

Abstract Background Although preoperative docetaxel, cisplatin, and fluorouracil (DCF) therapy is reportedly effective in patients with advanced esophageal squamous cell cancer (ESCC), long-term results after preoperative DCF therapy are not well known. We retrospectively reviewed the long-term results after preoperative DCF therapy. Methods This study includes 63 patients with advanced thoracic esophageal carcinoma (excluding T4 tumors) receiving preoperative chemotherapy between February 2010 and February 2014. All patients were intended to receive two courses of treatment every four weeks, or three courses every three weeks. Patients underwent curative surgery four to five weeks after completing chemotherapy. Results Radical resection was performed in 58 patients (92%). R0 resection was completed in 48 patients (83%). The 5-year overall survival and progression free survival were 55% [95% confidential interval, 0.41–0.66] and 0.46% [0.34–0.58], respectively. Recurrences occurred in 34 patients (54%). Distant metastases developed in 13/48 (27%) after R0 resection. Chemotherapy-related adverse events included G4 hematotoxicity (n = 50, 79%, neutrophil < 500), febrile neutropenia (n = 16, 25%), and G3 non-hematotoxicity (n = 15, 24%). Conclusion These results suggest that preoperative DCF therapy may be effective and improve the long-term outcomes in patients with advanced esophageal carcinoma. Disclosure All authors have declared no conflicts of interest.

A retrospective study of anlotinib in patients with cervical cancer after chemoradiotherapy.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e17509-e17509
Author(s):  
Liu Tan ◽  
Alan Chu ◽  
Yu Yang ◽  
Jinjin Yuan ◽  
Ge Hou ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Retrospective Study ◽  
Adverse Events ◽  
Objective Response ◽  
Progression Free Survival ◽  
Combination Group ◽  
Tyrosine Kinase Receptor ◽  
Secondary Endpoints ◽  
Grade 3 ◽  
Antiangiogenic Drug

e17509 Background: Anlotinib is a novel small molecule antiangiogenic drug, which can inhibit multiple tyrosine kinase receptor activity. Its antitumor activity has been proved in various cancers, including gynecological tumors. This retrospective study explored the efficacy and safety of anlotinib monotherapy or anlotinib combined chemotherapy in cervical cancer patients who have disease progressed or metastasis after chemoradiotherapy. Methods: 28 patients with cervical cancer admitted to the Second Affiliated Hospital of Zhengzhou University were enrolled. These patients who had received radiotherapy and at least one line chemotherapy had tumor progression or metastasis. 13 patients received anlotinib monotherapy (12mg/d from day 1 to day 14 in a 21-day cycle) and 15 patients received chemotherapy combined with the anlotinib. Treatment was continued until disease progression or death or intolerable adverse events. The primary endpoint was the objective response rate (ORR), and the secondary endpoints were disease control rate (DCR), progression-free survival (PFS) and safety. Results: As of Dec 31 2020, no one was lost follow up. 2 patients were still under treatment, and 26 patients were evaluable. 1 CR, 6 PR, 13 SD, 6 PD, yielding the ORR of 26.92%, and the DCR of 76.92%. The median PFS for receiving anlotinib monotherapy was 4.57 (95% CI, 3.85-5.29) months, and 8.47 (95% CI, 5.09-11.85) months for combination group. The most common adverse events (AEs)were grade 1, including hypertension (46.43%), anemia (42.85%) and fatigue (39.29%). Grade 3 AEs were hypertension(10.71%) and anemia(7.14%). No higher grade AEs occurred. Conclusions: Anlotinib is safe and effective for patients with advanced cervical cancer after chemoradiotherapy, and it is well tolerated.

Pathological Complete Response after Preoperative Chemotherapy with a Regimen Containing Trastuzumab in Esophagogastric Junction Adenocarcinoma: A Case Report

2016 ◽  
Author(s):  
Keisuke Arai ◽  
Shingo Kanaji ◽  
Daiki Okamoto ◽  
Ritsuko Maehara ◽  
Masashi Yamamoto ◽  
...  
Keyword(s):  
Epidermal Growth Factor Receptor ◽  
Growth Factor ◽  
Epidermal Growth Factor ◽  
Preoperative Chemotherapy ◽  
Esophagogastric Junction ◽  
Pathological Complete Response ◽  
Growth Factor Receptor ◽  
Complete Response ◽  
Esophagogastric Junction Adenocarcinoma ◽  
Epidermal Growth

Abstract ABSTRACT Introduction Perioperative adjuvant treatment for esophagogastric junction adenocarcinoma has been attempted, but efficacy of preoperative therapy is unclear. We report here a case of pathological complete response after preoperative treatment containing trastuzumab in esophagogastric junction adenocarcinoma. Case presentation A 54-year-old man presented at our institute with dysphagia. Esophagogastroduodenoscopy and computed tomography revealed an 8 x 5 cm-sized tumor on the gastric cardia and lower intrathoracic esophagus with invasion to the diaphragm (T4bN0M0, StageIIIB). Biopsy showed a well-differentiated and human epidermal growth factor receptor 2-positive adenocarcinoma. He received 2 cycles of preoperative chemotherapy consisting of trastuzumab, cisplatin, and capecitabine without severe toxicity. Afterwards, he underwent esophagectomy and total gastrectomy with mediastinal and abdominal D2 lymph node dissections. No cancer cells were detected during histopathological examination, indicating pathological complete response. Conclusion Regimens containing trastuzumab are feasible and promising as preoperative chemotherapy for human epidermal growth factor receptor 2-positive esophagogastric junction adenocarcinoma.

Updated analysis of HERBIS-1: A phase ll study of trastuzumab (T-mab) in combination with tri-weekly S-1 plus CDDP in HER2-positive advanced gastric cancer.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 98-98
Author(s):  
Makio Gamoh ◽  
Naotoshi Sugimoto ◽  
Hiroto Miwa ◽  
Masahiro Tsuda ◽  
Shinichi Nishina ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Antitumor Activity ◽  
Adverse Events ◽  
Advanced Gastric Cancer ◽  
Response Rate ◽  
Progression Free Survival ◽  
Event Analysis ◽  
Her2 Positive ◽  
Eligibility Criteria ◽  
Esophagogastric Junction Adenocarcinoma

98 Background: The HERBIS study demonstrated the promising antitumor activity and manageable toxicities of S-1 plus cisplatin and T-mab (SPT) regimen in patients (pts) with HER2-positive advanced gastric cancer (AGC) (Sugimoto et al. ASCO GI 2012, Abstract 70). We report the updated time-to event analysis. Methods: Main eligibility criteria were gastric or esophagogastric junction adenocarcinoma, HER2-positive, unresectable or recurrent, measurable lesion, no history of chemotherapy or radiotherapy, ECOG PS of 0-1 and adequate organ function. Pts received S-1(80-120mg / day) on days 1-14, cisplatin 60 mg/m2on day 1 and T-mab 8 mg/ kg on day 1 (6 mg/ kg from 2nd course) repeated every 3 weeks until disease progression. Primary endpoint was response rate (RR) and secondary endpoints were overall survival (OS), progression-free survival (PFS), time to treatment failure (TTF) and adverse events. The planned sample size was 50 pts. Results: A total of 56 pts were enrolled from July 2011 to May 2012. Two pts were ineligible and one patient did not receive any treatment. Therefore, the efficacy and safety analyses were conducted in the full analysis set of 53 pts. The confirmed response rate was 67.9% (95% CI: 53.7-80.1), and the disease control rate was 94.3% (95% CI: 84.3-98.9). Median OS was 16.0 months (95% CI: 13.3 - NaN), median PFS was 7.8 months (95% CI: 6.0 – 8.8) and median TTF was 5.7 months (95% CI: 4.2 - 7.1), respectively at the median follow-up time of 13.5 months. The main grade 3/4 adverse events were leukopenia 8%, neutropenia 36%, anemia 15%, increased creatinine 6%, hypoalbuminemia 9%, anorexia 23%, diarrhea 8% and vomiting 6%. Conclusions: SPT have promising antitumor activity and manageable toxicities in pts with HER2-positive AGC. Clinical trial information: UMIN000005739.

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