scholarly journals Neoadjuvant chemotherapy with cisplatin, 5-FU, and leucovorin (PLF) in locally advanced gastric cancer: a prospective phase II study

2003 ◽  
Vol 6 (3) ◽  
pp. 159-167 ◽  
Author(s):  
Katja Ott ◽  
Andreas Sendler ◽  
Karen Becker ◽  
Hans-Joachim Dittler ◽  
Hermann Helmberger ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Advanced Gastric Cancer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Locally Advanced ◽  
Locally Advanced Gastric Cancer ◽  
Prospective Phase

A phase II study of neoadjuvant chemotherapy with a modified FOLFOX6 regimen for locally advanced gastric cancer.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 81-81
Author(s):  
Xiang Wang ◽  
Lin Zhao ◽  
Hongfeng Liu ◽  
Chunmei Bai ◽  
Xiaoyi Li
Keyword(s):  
Gastric Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Advanced Gastric Cancer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Locally Advanced ◽  
Postoperative Chemotherapy ◽  
Regression Rate ◽  
Locally Advanced Gastric Cancer ◽  
Laurén Classification

81 Background: The aim of this study was to evaluate the efficacy and safety of neoadjuvant chemotherapy with the mFOLFOX6 regimen in gastric cancer patients. Methods: This study was a single-arm phase II study. 73 patients with histologically confirmed locally advanced gastric cancer (T2-T4 or N+) were enrolled. The patients were administered the mFOLFOX6 regimen for 3 cycles. Surgery was scheduled 3-4 weeks after the completion of the chemotherapy. Postoperative chemotherapy began 4 weeks after surgery, and the program choice was based on the results of patients’ clinical/pathological evaluations. Perioperative efficacy, toxicity, effects of surgery, postoperative observation, and prognosis were studied. Survival analysis was performed to identify the relationship between the response and outcome and to identify factors predictive of OS. Results: 73 patients received the neoadjuvant chemotherapy, and 67 (91.8%) completed all of the preoperative cycles, with grade 3-4 toxicity arising in 33.0%. Surgery was performed in 71 (97.3%) patients, and radical resection was achieved in 67 (91.8%) patients. Postoperative chemotherapy started in 63 (88.7%) patients. The radiology response rate of chemotherapy was 45.8%. Among the patients who underwent radical surgery, pT downstaging was observed in 22 (32.8%) patients and pN downstaging was observed in 17 (25.4%) patients. All of the patients showed different levels of histological regression of the primary tumour, with a ≥ 50% regression rate of 49.2% and a pCR rate of 3.0%. Univariate analysis identified factors that were associated with OS, including local tumour infiltration, Lauren classification, pre-chemotherapy N stage, ypTNM stage, and pathologic regression rate (GHR)( ≥ 2/3/ < 2/3, ≥ 50%/ < 50%). Multivariate analysis identified both ypTNM stage and Lauren classification as independent predictors of survival. Conclusions: The mFOLFOX6 regimen was very effective and well-tolerated as a neoadjuvant chemotherapy for locally advanced gastric cancer. The ypTNM stage could serve as an independent predictor of survival. GHR ≥ 50% / < 50% could be used as a surrogate marker to guide the selection of a postoperative chemotherapy regimen. Clinical trial information: NCT02226380.

Phase II study of neoadjuvant chemotherapy and extended surgery for locally advanced gastric cancer

2009 ◽  
Vol 96 (9) ◽  
pp. 1015-1022 ◽  
Author(s):  
T. Yoshikawa ◽  
M. Sasako ◽  
S. Yamamoto ◽  
T. Sano ◽  
H. Imamura ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Advanced Gastric Cancer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Locally Advanced ◽  
Extended Surgery ◽  
Locally Advanced Gastric Cancer

Apatinib plus SOX regimen as neoadjuvant chemotherapy for locally advanced gastric cancer: A phase II study.

2018 ◽  
Vol 36 (15_suppl) ◽  
pp. e16014-e16014
Author(s):  
Ya'nan Zheng ◽  
Xiao Yang ◽  
Hongpeng Shi ◽  
Zhongyin Yang ◽  
Chao Yan ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Advanced Gastric Cancer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Locally Advanced ◽  
Locally Advanced Gastric Cancer

The quality of life (QoL) assessment of oxaliplatin-based preoperative chemotherapy for locally advanced gastric cancer: An integration analysis of two prospective phase I study.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18263-e18263
Author(s):  
Hironaga Satake ◽  
Akira Miki ◽  
Hisateru Yasui ◽  
Akihito Tsuji
Keyword(s):  
Gastric Cancer ◽  
Lymph Node ◽  
Neoadjuvant Chemotherapy ◽  
Phase I ◽  
Advanced Gastric Cancer ◽  
Phase I Study ◽  
Locally Advanced ◽  
Node Dissection ◽  
Locally Advanced Gastric Cancer ◽  
Prospective Phase

e18263 Background: Surgery with lymph node dissection is the primary treatment for patients with localized resectable gastric cancer. However, the prognosis of locally advanced gastric cancer is poor. One promising approach is neoadjuvant chemotherapy, however, the use of neoadjuvant chemotherapy consisting of oxaliplatin-based regimen for locally advanced gastric cancer has not been reported. Oxaliplatin-induced neurotoxicity may continue after the chemotherapy and interfere with patients’ daily activities. We conducted two prospective phase I study of oxaliplatin-based neoadjuvant chemotherapy for locally advanced gastric cancer and assessed the oxaliplatin-induced neuropathy using the FACT-Ga and FACT-GOG-Ntx assessments. Methods: We planned two cycles of oxaliplatin administration and evaluated oxaliplatin-induced neuropathy using the FACT-Ga and FACT-GOG-Ntx assessments. Patients with locally advanced gastric cancer received two cycles of neoadjuvant chemotherapy with oxaliplatin (100 or 130 mg/m2) on day 1, as well as S-1 (80 mg/m2/day, b.i.d.) or capecitabine (2000 mg/m2/day, b.i.d.) for 14 days, repeated every 3 weeks. They then underwent gastrectomy with curative D2/3 lymph-node dissection followed by adjuvant S-1 (80 mg/m2/day, b.i.d.) for one year. QoL was assessed at baseline and during treatment. Results: Twelve patients were enrolled and fully assessed the QoL. All patients were chmo-naïve and had a good performance status: median age 70y, 67% male. The mean dose intensity of delivered during the neoadjuvant chemotherapy was 96.0% for oxaliplatin. Peripheral neuropathy was observed in all patients but with no functional disorders. Median time to QoL deterioration in FACT-G and FACT-GOG-NTx was 3 weeks. There were correlation between oxaliplatin administration and QoL deterioration by the repeated-measures ANOVA. Conclusions: FACT-GOG-Ntx showed that sensory neuropathy caused a deterioration in QoL immediately after the initiation of preoperative oxaliplatin-based chemotherapy, but that QoL recovered after the neo-adjuvant chemotherapy. Clinical trial information: UMIN000015950,UMIN000015181.

Phase II trial of S-1 combined with oxaliplatin (SOX) as neoadjuvant chemotherapy for locally advanced gastric cancer.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 122-122
Author(s):  
L. Chen
Keyword(s):  
Gastric Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Advanced Gastric Cancer ◽  
Phase Ii ◽  
Response Rate ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
High Response Rate ◽  
R0 Resection ◽  
Locally Advanced Gastric Cancer

122 Background: Previous phase II trial with combination therapy of S-1 plus oxaliplatin (SOX) demonstrated high response rate and well tolerability in patients with untreated advanced gastric cancer. The aim of this phase II trial was to evaluate the efficacy and safety of SOX as neoadjuvant chemotherapy for locally advanced gastric cancer (AGC). Methods: Eligibility criteria included a histologically proven AGC with stage IIIb, IIIc (AJCC 7th edition), at least 1 measurable lesion, no prior chemotherapy, ECOG 0∼2, adequate hepatic, renal, and bone marrow function. Enrolled patients were staged by EUS and CT. The neoadjuvant chemotherapy consisted of 3-4 cycles of oxaliplatin (130 mg/m2) on day 1 and S-1 (80 mg/m2/day) for 14 days with 7 days rest. After chemotherapy, the patients underwent surgery. Results: From Dec 2009 to Sep 2010, 35 patients (IIIb; 19pts, IIIc; 16pts) were enrolled. The median age of the patients was 54.6 years (range; 20-72 y). All patients were available for evaluating the clinical responese and adverse events. The overall response rate was 68.5% (1CR, 23 PR, 9 SD, 2 PD). 32 patients underwent surgical resection. Of them, 27 patients underwent standard D2 surgery and 5 patients had palliative surgery. 25 patients had R0 resection. Postoperative pathological examination showed that most of the surgical patients were in T4a stage. According to Lauren classification, 71.9% patiens (23/32pts) were diffuse type, SOX showed higher respons rate (1CR, 20 PR, 2 SD, RR: 91.3%) among these patients. Major grade 3/4 hematological toxicities were anemia (5.7%), neutropenia (5.7%) and liver dysfunction (8.6%) and non-hematological toxicities were anorexia (5.7%) and vomiting (11.4%). But most of the adverse events were managable. Conclusions: Neoadjuvant chemotherapy with S-1 plus oxaliplatin (SOX) showed high response rate and and R0 resection rate for locally advanced GC, especially for diffuse type patients. All the patients did not have severe toxicity during the process of chemotherapy. This is the preliminary results, and the survival benefit in locally advanced GC patients that respond to SOX neoadjuvant chemotherapy needs to be addressed by a randomized-controlled trial. No significant financial relationships to disclose.

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