Phase II study of S-1 and oxaliplatin as neoadjuvant chemotherapy for locally advanced adenocarcinoma of the gastric or esophagogastric junction: KSCC1601

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.

Download Full-text

FOxTROT: Randomized phase II study of neoadjuvant chemotherapy with or without an anti-EGFR monoclonal antibody for locally advanced, operable colon cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2010.28.15_suppl.tps192 ◽

2010 ◽

Vol 28 (15_suppl) ◽

pp. TPS192-TPS192

Author(s):

R. G. Gray ◽

D. Morton ◽

G. Brown ◽

D. R. Ferry ◽

L. Magill ◽

...

Keyword(s):

Monoclonal Antibody ◽

Colon Cancer ◽

Neoadjuvant Chemotherapy ◽

Phase Ii ◽

Phase Ii Study ◽

Locally Advanced ◽

Randomized Phase Ii

Download Full-text

Phase II study of paclitaxel and capecitabine (PX) combination as neoadjuvant chemotherapy for unresectable locally advanced gastric cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.e15164 ◽

2013 ◽

Vol 31 (15_suppl) ◽

pp. e15164-e15164

Author(s):

Yoon Ho Ko ◽

Sook Hee Hong ◽

Sang Young Roh ◽

Kyo Young Song ◽

Eun Sun Jung ◽

...

Keyword(s):

Neoadjuvant Chemotherapy ◽

Phase Ii ◽

Metabolic Response ◽

Phase Ii Study ◽

Multidisciplinary Treatment ◽

Locally Advanced ◽

Complete Response ◽

R0 Resection ◽

Regional Lymph Nodes ◽

Locally Advanced Gastric Cancer

e15164 Background: Unresectable locally advanced adenocarcinoma (AGC) of the stomach is associated with poor prognosis due to the lack of effective treatment. Neoadjuvant chemotherapy (NAC) has drawn more attention to the treatment of locally AGC in the current multidisciplinary treatment model. Paclitaxel and capecitabine (PX) has been used in palliative setting with good response rates but its role in a neoadjuvant setting is not well established. This phase II study was performed to evaluate the efficacy and safety of neoadjuvant PX chemotherapy in patients with unresectable locally AGC. Methods: Patients with AGC, clinically unresectable because of local invasion and/ or conglomerated regional lymph nodes (station 7, 8, and 9) metastasis on based on laparoscopic staging, were enrolled. PX consisted of paclitaxel 175 mg/m2 i.v. on day 1, and capecitabine 835 mg/m2 twice daily p.o. on days 1–14 every 21 days. After three cycles of NAC, patients with clinically resectable AGC underwent surgical resection. Results: This trial was stopped for poor accrual after 18 patients were enrolled; 50% patients had tumors located in the proximal third of the stomach. Seventeen patients finished three cycles of chemotherapy. The overall response rate was 41.2% (7/17 cases), of which 71.4% (10/14 cases) metabolic response. Fourteen (77.8%) of the 18 patients enrolled underwent surgery, and 12 (85.7%) had an R0 resection. Pathological complete response was observed in one (7.1%) of patients. Toxicity was mild to moderate and there were no treatment-related deaths and no major surgical complications. With a median follow-up of 28.6 months (range 6.4-38.4 months), the 2-year survival rate for all patients was 71.1%. Subgroup analysis found R0 resection (35.7 months vs. 20.6 months, P= 0.005) and patients with pathologic N downstaging (P < 0.001) to have improved overall survival. Conclusions: Neoadjuvant chemotherapy with PX shows promising results in unresectable locally AGC patients without increased morbidity and mortality. Neoadjuvant PX may permit a larger chance of curative resection in unresectable locally AGC patients.

Download Full-text