Efficacy of 3-day versus 5-day aprepitant regimens for long-delayed chemotherapy-induced nausea and vomiting in patients receiving cisplatin-based chemotherapy

Chemotherapy-induced nausea and vomiting (CINV) is an ongoing problem. While effectiveness of triplet antiemetic regimens in the delayed CINV phase (24–120 hours after administration of chemotherapy) has been studied, their effectiveness in the long-delayed phase (120–168 hours post-administration) is unknown. We compared the efficacy of 3- and 5-day courses of a triplet antiemetic prophylaxis containing aprepitant (APR) in controlling long-delayed CINV after cisplatin (CDDP)-based chemotherapy. We obtained patient-level data from a nationwide, multicenter, prospective observational study in Japan. The incidence and timing of CINV after 3- and 5-day APR-containing regimens were compared using inverse probability treatment weighting. The analysis included 380 patients. The incidence rates of long-delayed nausea and vomiting were significantly reduced for the 5-day compared with the 3-day regimen (29.1% vs. 22.2%, p = 0.0042; 6.7% vs. 0%, p  A 5-day regimen triplet antiemetic prophylaxis with APR decreased long-delayed vomiting compared with a 3-day regimen in patients receiving CDDP-based chemotherapy. However, the 5-day regimen showed no advantage over the 3-day regimen against long-delayed nausea.</p

Representative pictures of anti-CD44v9-antibody immunostaining.

<p>The staining intensity obtained in the basal cells of normal epithelium was used as a control (A). Tumor samples demonstrated strong (B), moderate (C), and weak (D) intensities relative to the control (A). Respective positive (E) and negative <u>(F</u>) stainings. Bar indicates 200 um.</p

(A) Disease specific survival curves of all patients (n = 102) according to the chemoradioselection.

<p>(B) Disease specific survival curves based on the CD44 v9 positivity of biopsy samples (n = 60) obtained from 30 chemoradioselected (CRS) patients and 30 non-chemoradioselected (N-CRS) patients. (C) Disease specific survival curves based on the CD44 v9 positivity of biopsy samples obtained from 30 N-CRS patients.</p

(A) Disease specific survival curves based on the CD44 v9 positivity of surgically removed samples obtained from 72 non-chemoradioselected (N-CRS) patients.

<p>(B) Diseasespecific survival curves of 30 N-CRS patients who had paired biopsy and surgically removed samples. The patients were divided into 2 groups according to their levels of CD44v9 expression before and after concurrent chemoradiotherapy.</p

Patient characteristics (<i>N</i> = 102).

<p>Patient characteristics (<i>N</i> = 102).</p

Proposed roles of CD44v9-expressing CSC and non-CSC in the chemoradioselection.

<p>(A) CD44v9-expressing non-CSCs are sensitive to CCRT. Intrinsic CD44v9-expressing CSCs (B) or CCRT-induced CD44v9-expressing CSCs (C) can survive CCRT. These CD44v9-expressing CSCs are considered to be highly invasive and metastatic. CSC, cancer stem cell; CCRT, concurrent chemoradiotherapy; CRS, chemoradioselected; and N-CRS, non-chemoradioselected.</p

Additional file 1: of A randomized phase II study to assess the effect of adjuvant immunotherapy using α-GalCer-pulsed dendritic cells in the patients with completely resected stage II–IIIA non-small cell lung cancer: study protocol for a randomized controlled trial

SPIRIT 2013 Checklist: recommended items to address in a clinical trial protocol and related documents*. (DOC 123 kb