CISNE is a valid model for accurately classifying patients with cancer with seemingly stable FN episodes.

Background:We sought to develop and externally validate a nomogram and web-based calculator to individually predict the development of serious complications in seemingly stable adult patients with solid tumours and episodes of febrile neutropenia (FN).Patients and methods:The data from the FINITE study (n=1133) and University of Salamanca Hospital (USH) FN registry (n=296) were used to develop and validate this tool. The main eligibility criterion was the presence of apparent clinical stability, defined as events without acute organ dysfunction, abnormal vital signs, or major infections. Discriminatory ability was measured as the concordance index and stratification into risk groups.Results:The rate of infection-related complications in the FINITE and USH series was 13.4% and 18.6%, respectively. The nomogram used the following covariates: Eastern Cooperative Group (ECOG) Performance Status ⩾2, chronic obstructive pulmonary disease, chronic cardiovascular disease, mucositis of grade ⩾2 (National Cancer Institute Common Toxicity Criteria), monocytes <200/mm3, and stress-induced hyperglycaemia. The nomogram predictions appeared to be well calibrated in both data sets (Hosmer–Lemeshow test, P>0.1). The concordance index was 0.855 and 0.831 in each series. Risk group stratification revealed a significant distinction in the proportion of complications. With a ⩾116-point cutoff, the nomogram yielded the following prognostic indices in the USH registry validation series: 66% sensitivity, 83% specificity, 3.88 positive likelihood ratio, 48% positive predictive value, and 91% negative predictive value.Conclusions:We have developed and externally validated a nomogram and web calculator to predict serious complications that can potentially impact decision-making in patients with seemingly stable FN.

Thirty-four patients with metastatic breast cancer (MBC) who had progression of disease after high-dose chemotherapy (HDCT) with peripheral blood progenitor cell support (PBPC) had methotrexate, uracil and tegafur (UFT), and leucovorin (MUL) therapy administered: methotrexate administered intramuscularly in combination with UFT given orally and leucovorin given orally. All patients had received extensive prior chemotherapy including a high-dose regimen with PBPC support. Two complete responses (CR) and 11 partial responses (PR) were observed (objective response rate: 13/34 or 38%, 95% confidence interval 22-56%). Seven additional patients had stable disease (SD), 4 of whom (12% of the total population) of 6 months or longer duration, with the clinical benefit rate (CR + PR + SD of at least 6-month duration) reaching 50%. Median follow-up was 38 months, and the median time to progression and the median overall survival time from the start of MUL were 5.5 and 11 months, respectively. Toxicity was mainly gastrointestinal. Eight patients (24%) had World Health Organization grade II or greater diarrhea and/or enteritis and, consequently, the UFT dose was reduced. Emesis was mild and easily manageable with thiethylperazine given orally. The regimen did not produce significant myelosuppression or alopecia. In conclusion, patients with MBC retain chemosensitivity even when they progress after HDCT/PBPC and can be treated again with chemotherapy. MUL is active and well tolerated in patients with MBC progressing after HDCT. Further studies with this regimen, as salvage chemotherapy or as maintenance chemotherapy after HDCT/PBPC, would appear to be warranted.

e12629 Background: Adyuvant therapy with Concurrent docetaxel-adriamycin-cyclophosphamide (TAC) increases overall survival in positive node breast cancer. However it is associated with an increased risk of infection and cardiotoxicity. Switching to epirubicin (TEC) and adding Filgrastim prophylaxis (GCSF) could be an useful and safe option in the neoadjuvant setting. Methods: We reviewed the efficacy and safety of neoadjuvant regimen TEC x 6 cycles(c) and GCSF in HNBC. Kaplan–Meier, Cox regression and binary logistic regression were performed to analyze survival prognostic factors, pathological complete response rate (pCR) and serious adverse events. Results: From 2015 to 2021, 204 patients (pt) and 1125 cycles were registered. Median follow-up of 39.4 months. Median age 48 years (SD 8.3), stage II to IIIC (35% IIB), 64% were positive node and 25% Triple Negative(TN) tumors. A median dose of 90% (87.9-93.4) was administered, 93% with a cumulative dose higher than 66% (equivalent to 4 c). Radiologic response in 75% pt. 16.3% pt achieved pCR (3.2% in LumA, 15% in LumB and 35% in TN tumors). OR 4.98 (2.18-11.35) for TN and OR 0.94 (0.89-0.99) for older p<0.05. No relapses were detected in TN patients with PCR. PCR was non-inferior in pt who received 66% of planned dose (OR 1.3, p=0.76) and was higher in LumB than LumA, OR 5.2 (1.13- 24.61), p <0.05. Lymphadenectomy was avoided in 29.2% of patients with affected node at baseline. 3 years (y) relapse free (F) survival (S) of 86.1% (91-80%), better prognosis in stage II HR 0.29 (0.14-0.58) and older HR 0.93 (0.89-0.98), p< 0.005. 3y overall FS of 89% (93-84%), worse prognosis in TN with HR 3.48 (1.37-8.84). Lower risk in stage II with HR 0.31 (0.13-0.75) and in Pegfilgastrim with HR 0.14 (0.03-0.67), p<0.05. Hospital admissions in 24% for any cause. Older age (OR 1.05, p=0.01). 21% neutropenia G3/4. Infections in 17.2% of pt. Febril neutropenia in 18.1%, no related to age (p=0.5) or pegfilgrastim Vs filgrastim (p=0.99). Asthenia 17%, colitis 6% and thrombosis in 2%. No cardiacs events were reported. Conclusions: TEC is effective in the neoadjuvant setting of HNBC. It has similar pCR and survivall to those reported in meta-analysis. GCSF facilitates treatment compliance but the risk of neutropenia and admissions are still present. A lower cumulative dose could be enough to achieve the same results. Stage III and TN have shown a worse prognosis.