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Background: This study evaluated the non-inferiority of dexamethasone (DEX) on day 1, with sparing on days 2–4 in cisplatin-based chemotherapy. Methods: Patients with malignant solid tumors who were treated with cisplatin (≥50 mg/m²) were randomly assigned (1:1) to receive either DEX on days 1–4 (Arm D4) or DEX on day 1 (Arm D1) plus palonosetron, NK-1 RA, and olanzapine (5 mg). The primary endpoint was complete response (CR) during the delayed (24–120 h) phase. The non-inferiority margin was set at −15%. Results: A total of 281 patients were enrolled, 278 of whom were randomly assigned to Arm D4 (n = 139) or Arm D1 (n = 139). In 274 patients were included in the efficacy analysis, the rates of delayed CR in Arms D4 and D1 were 79.7% and 75.0%, respectively (risk difference −4.1%; 95% CI –14.1%–6.0%, P = 0.023). However, patients in Arm D1 had significantly lower total control rates during the delayed and overall phases, and more frequent nausea and appetite loss. There were no significant between-arm differences in the quality of life. Conclusion: DEX-sparing is an alternative option for patients receiving cisplatin; however, this revised administration schedule should be applied on an individual basis after a comprehensive evaluation. Clinical Trials Registry number: UMIN000032269 [ABSTRACT FROM AUTHOR]

Background: This randomized study was designed to evaluate the clinical effect of an elemental diet during chemotherapy in patients with esophageal cancer. Methods: The inclusion criteria were as follows: (1) esophageal squamous cell carcinoma, (2) stage IB-IV, (3) schedule to receive docetaxel, cisplatin, and 5-fluorouracil (DCF chemotherapy), (4) 20–80 years old, (5) performance status of 0–2, (6) oral intake ability, and (7) written informed consent. Patients were divided into two groups: the elemental supplementary group and the non-supplementary group. Patients received ELENTAL® (160 g/day) orally 9 weeks after the start of chemotherapy. Primary endpoint was the incidence of grade 2 or higher gastrointestinal toxicity according to the Common Terminology Criteria for Adverse Events, version 4.0. Secondary endpoints were the incidence of all adverse events and the evaluation of nutritional status. Results: Thirty-six patients in the elemental supplementary group and 35 patients in the non-supplementary group were included in the analysis. The incidence of grade 2 or higher gastrointestinal toxicity and all grade 3 or 4 adverse events did not differ significantly between the groups. In the elemental supplementary group, the body weight (p = 0.057), muscle mass (p = 0.056), and blood levels of transferrin (p = 0.009), total amino acids (p = 0.019), and essential amino acids (p = 0.006) tended to be maintained after chemotherapy. Conclusion: Nutritional support provided by an amino acid-rich elemental diet was ineffective for reducing the incidence of adverse events caused by DCF chemotherapy in patients with esophageal cancer. [ABSTRACT FROM AUTHOR]

Background: Neoadjuvant chemotherapy (NAC) has become prevalent in esophageal squamous cell carcinoma (ESCC), but its long-term prognostic advantages remain unclear. The latest prognostic outcomes in clinical Stage (cStage) II/III ESCC with NAC were herein elucidated. Patients and Methods: NAC prior to curative treatment was done in 115 cStage II/III ESCC patients with either cisplatin (CDDP)/5-fluorouracil (5-FU; CF) (n = 41) or docetaxel/CDDP/5-FU (DCF) NAC (n = 74) between 2007 and 2013. Results: (1) Esophagectomy was finally performed in 35 of the 41 CF NAC cases and in 48 of the 74 DCF NAC cases. The preservation rate of the esophagus was higher in the DCF NAC than in the CF NAC (p = 0.018). (2) The overall survival was better in DCF NAC than in CF NAC (p = 0.071), and progression-free survivals were 58.3% with DCF and 30.5% with CF (p = 0.0060). DCF NAC was associated with fewer cases of progression than CF NAC (p = 0.0040), largely due to excellent control of the preoperative disease (p = 0.018) and postoperative lymph node recurrence (p = 0.014). Conclusion: DCF NAC in cStage II/III ESCC could have a great potential to achieve a better prognosis due to suppression of specific progression events with a higher preservation rate of the esophagus. [ABSTRACT FROM AUTHOR]

Background: Combined chemotherapy with cisplatin, 5-fluorouracil, and docetaxel (DCF) is a promising regimen for the treatment of esophageal squamous cell carcinoma (ESCC). However, careful attention must be paid to severe neutropenia. Methods: A total of 17 patients with ESCC who received DCF therapy (docetaxel 75 mg/m on day 1, cisplatin 75 mg/m on day 1, and 5-fluorouracil 750 mg/m on days 1-5) were studied from December 2010 through May 2012. We assessed the relation between neutropenia and the plasma concentration of each anticancer drug during the first course of DCF therapy. Results: The maximum plasma concentration ( C) (mean ± SD) of docetaxel was 1,929 ± 458 ng/mL, while that of cisplatin was 2,870 ± 410 ng/mL, and that of 5-fluorouracil was 448 ± 121 ng/mL. The area under the plasma concentration-time curve (AUC) (mean ± SD) as calculated by MOMENT analysis was 2,428 ± 513 ng/mL h for docetaxel and 135,950 ± 22,330 ng/mL h for cisplatin. The AUC of 5-fluorouracil was not calculated. Higher C and AUC values for docetaxel were associated with trends toward lower nadir absolute neutrophil counts (ANCs). The C of docetaxel reflected the AUC of docetaxel. Neither the C nor AUC of docetaxel was related to the occurrence of febrile neutropenia. Conclusions: Higher C or AUC values of docetaxel are associated with a trend toward lower nadir ANCs in patients with ESCC who receive DCF therapy. The C of docetaxel, which is assessable immediately after starting treatment, might be useful for predicting the severity of the nadir ANC or for selecting the management method. [ABSTRACT FROM AUTHOR]

Background: Our aim in this study is to know whether clinical outcomes are improved by neoadjuvant chemotherapy (NAC) using Docetaxel/CDDP/5-FU (DCF) as compared to NAC using 5-FU/CDDP (FP). Methods: Thirty-eight patients who underwent DCF NAC in cStage II/III esophageal squamous cell carcinoma (ESCC) were compared with the 41 counterparts treated by FP NAC. Docetaxel and CDDP were both given to 70-75 mg/m with concurrent 5-FU at 750 mg/m in 3 cycles. Median follow-up term of DCF NAC reached 27 months. Results: In DCF NAC, grade 3 adverse effects were recognized in 97 %, and completion rate of the DCF NAC was 86 %. In terms of PR + CR rate, DCF NAC was better (87 %) than FP NAC (59 %) ( p = 0.005). Five year progression-free survival (PFS) and overall survival (OS) of FP NAC were 32 and 69 %, respectively, and OS of FP NAC was excellent putatively due to adoption of definitive chemoradiation therapy for recurrent diseases. Furthermore, survival was in favor of DCF NAC as compared to FP NAC for OS ( p = 0.02) and PFS ( p = 0.10), while R0 resection rate was similar. The 1st multivariate prognostic analysis among all cases with NAC revealed that significant factors were resectability and NAC modality for OS and PFS. We then performed the 2nd stage multivariate prognostic analysis limited to R0 cases including pathologic factors, which again identified DCF NAC modality as an independent prognostic factor. Conclusion: DCF NAC for ESCC demonstrated high response rates, and may improve patient survival with acceptable feasibility. [ABSTRACT FROM AUTHOR]

Background: Neoadjuvant or induction chemotherapy with docetaxel, cisplatin, and 5-fluorouracil (DCF) is regarded as one of the most promising regimens for locally advanced esophageal squamous cell carcinoma (ESCC), but has a high incidence of adverse events. We retrospectively evaluated adverse events in patients with ESCC who received DCF. Methods: Between December 2009 and May 2012, 57 patients with Stage II to IV locally advanced ESCC received three cycles of DCF (docetaxel 70-75 mg/m, day 1; cisplatin 70-75 mg/m, day 1; 5-fluorouracil, 750 mg/m, days 1-5) as neoadjuvant or induction chemotherapy in a single institution. Adverse events of DCF were evaluated retrospectively. Results: The median age of the subjects was 65 years (range 41-74). Fifty-four patients (95 %) received three cycles of DCF as scheduled. Dose modifications were made for 34 patients (60 %). There were no treatment delays or unplanned admissions. Grade 3 or 4 neutropenia developed in 53 patients (93 %), including 18 (32 %) with febrile neutropenia. Other grade 3 or 4 toxic effects were hyponatremia in 15 patients (26 %), hypokalemia in 10 (18 %), oral mucositis in 9 (16 %), diarrhea and hypocalcemia in 8 (14 %) each, fatigue in 4 (7 %), and vomiting, anorexia, hiccups, hypoalbuminemia, and elevations of alanine aminotransferase in 1 (2 %) each. No treatment-related deaths occurred within 30 days after completion of DCF. Conclusions: For patients with locally advanced ESCC, neoadjuvant or induction chemotherapy with DCF is tolerable. DCF is a viable treatment option for fit patients with locally advanced ESCC. [ABSTRACT FROM AUTHOR]