Jian Xiao

Nomogram basing pre-treatment parameters predicting early response for locally advanced rectal cancer with neoadjuvant chemotherapy alone: a subgroup efficacy analysis of FOWARC study

Objective To develop an accurate model with pre-treatment parameters to predict tumor regression and down-staging in locally advanced rectal cancer patients, basing the cohort of preoperative chemotherapy alone in FOWARC study. Patients and Methods From Jan 2011 to Feb 2015, complete data was available for 137 out of 165 patients who received preoperative chemotherapy alone. All pre-treatment clinical parameters were collected. Tumor regression grade (TRG) 0-1 was defined as good regression, and pathological TNM stage (ypTNM) 0-I after neoadjuvant treatment was defined as good down-staging. Nomogram was established to predict tumor regression and down-staging. The predictive performance of the model was assessed with concordance index and calibration plots. Results Of the 137 patients, 10 had TRG 0 (complete regression); 32 patients, TRG 1; and 95 patients, TRG 2 and 3 (poor regression); 56 (40.9%) patients were classified as good down-staging with ypTNM stage 0-I. The predictive nomograms were developed to predict the probability of TRG 0-1 and good down-staging with a C-index of 0.72 (95% CI: 0.604-0.797) and 0.76 (95% CI: 0.681-0.844). Calibration plots showed good statistical performance on internal validation. Predictive factors in the models included tumor length, tumor circumferential extent, age, and ApoA1. Conclusions The model based on available clinical parameters could accurately predict early efficacy with neoadjuvant mFOLFOX6 chemotherapy alone, which might help in patient selection for optimized treatment.

Neoadjuvant chemotherapy alone with mFOLFOXIRI in locally advanced rectal cancer: A single-arm phase II study.

TPS783 Background: Pre-operative 5-Fu based chemoradiation is still the standard of treatment for locally advanced rectal cancer (LARC). Although local recurrence rate had been controlled, about 30% of patients will develop distant metastases, which is the main obstacle for improving survival of LARC. Besides, preoperative radiation causes lots of concerns about anal and sexual functions. Whether systemic chemotherapy alone is effective enough in treating rectal cancer is not yet known. In our previous study of neoadjuvant mFOLFOX6 with or without radiotherapy in LARC, about 30% of patients in the arm with chemotherapy alone showed good response. And FOLFOXIRI had showed higher response rate in metastatic colorectal cancer. This phase II study is to explore whether pre-operative FOLFOXIRI could further improve the ratio of tumor downstaging (ypT0-2N0) in LARC. Methods: The primary endpoint is the ratio of tumor downstaging to ypT0-2N0M0 (pCR and stage I).The secondary endpoint included pathologic complete...

Nomogram including pretherapeutic parameters for prediction of early response after neoadjuvant treatment in rectal cancer: Results from a prospective randomized study.

716 Background: To establish a clinical nomogram with pretherapeutic parameters for predicting pathologic complete response (pCR) and tumor downstaging after neoadjuvant treatment in patients with rectal cancer. Methods: From Jan 2011 to Feb 2015, complete data was available for 309 patients with rectal cancer who received concurrent chemoradiotherapy or chemotherapy alone enrolled in FOWARC study. All pre-treatment clinical parameters were collected to build a nomogram for pCR and tumor down-staging. The model was subjected to bootstrap internal validation. The predictive performance of the model was assessed with concordance index (c-index) and calibration. Results: Of the 309 patients, 55 (17.8%) had achieved pCR, 138 (44.7%) patients were classified as good down-staging with ypTNM stage 0-I. Basing on the multivariate logistic regression and clinical consideration, 5 factors were identified to be the independent predictors for pCR and good downstaging, respectively (Table 1). The predictive nomograms ...

A pilot study of FOLFOX with or without radiation in treating patients with locally advanced rectal cancer.

e14147 Background: Preoperative 5FU-based chemo plus radiation therapy is standard for patients (pts) with locally advanced rectal cancer (RC). We conducted a pilot feasibility trial of adding the third generation drug oxaliplatin to the standard treatment to see whether the treatment outcome can be improved and the place of RT can be replaced.nnnMETHODSnPts with clinical stage II-III resectable RC were treated with 4 cycles of FOLFOX (CT) or 5 cycles of FOLFOX with radiation (2Gy/fraction, total 46Gy, CRT). Pts then were re-imaged and had repeat colonoscopy with MRI to assess the primary tumor response. Those with progressive disease in FOLFOX group were to be referred for pre-op 5FU plus RT, followed by surgery, and those with clinical regression/stable disease were to have surgery without pre-op RT. Post-op 5FU plus RT was planned for any pts who did not have an R0 resection. 7-8 cycles of FOLFOX were recommended in Post-op chemo. The primary endpoint was the objective response rate. Secondary outcomes were the pathologic CR rate, the 3-year disease free survival and local recurrence (LR) rate.nnnRESULTSnOf 51 pts were accrued since April 2007, 25 have completed pre-op RCT, 26 who have completed pre-op CT, 7 of 25 RCT pts (28%) had a path CR, however no pts with CT had path CR, the difference was significant. ORR was 92%, 80.8% and disease control rate (DCR) 96%, 96.2% respectively, there was no difference between the two groups. The quality of life was better and the in-hospital time was shorter the CT alone group. Local and distant recurrence rate data are immature. But so far, no recurrence was found in the CT group, which indicated the potential benefit of CT alone in the adjuvant setting.nnnCONCLUSIONSnPreliminary results of this pilot trial depicts that preoperative FOLFOX alone without RT achieves a high rate of DCR. And FOLFOX with RT achieves a high rate of CR. Further phase III trials are warranted.