Dexamethasone Sparing with Cisplatin-Based Chemotherapy Does Not Significantly Impact QoL

Dexamethasone sparing in cisplatin-based chemotherapy did not impair global health status, although it did worsen nausea and appetite loss.

Dexamethasone sparing in cisplatin-based chemotherapy did not impair global health status, although it did worsen nausea and appetite loss, according to patient-reported outcome findings from the phase 3 SPARED trial (UMIN000032269) presented at the 2022 Multinational Association of Supportive Care in Cancer Annual Meeting.

The global health status assessed by the EORTC QLQ-C30 questionnaire was slightly higher in the arm that received dexamethasone on day 1 only (arm D1) compared with the arm that was treated with dexamethasone on days 1 through 4 (arm D4; P = .38). Patients in the 2 arms also scored similarly on the symptom scales in terms of fatigue (P = .17), pain (P = .19), dyspnea (P = .81), insomnia (P = .41), diarrhea (P = .26), and financial difficulties (P = .96). Additionally, the 2 arms were close on the functional scales evaluating emotional (P = .75), cognitive (P = .13), and social (P = .42) wellbeing.

However, appetite loss by the EORTC QLQ-C30 scale was worsened in arm D1 compared with arm D4 (P < .01). The overall no nausea rate was 62.32% vs 50%, respectively (P = .04). Among patients with a nausea numeric rating scale (NRS) score of at least 1, the overall severity of nausea favored arm D1 (P = .04). In patients with significant nausea (NRS > 3), the overall rates were more closely aligned between the 2 arms (P = .29).

The overall no vomiting rate was very similar between the 2 arms: 94.93% and 94.12%, respectively (P = .77).

Dexamethasone is a steroid which is often administered to patients about to undergo high-emetogenic chemotherapy in order to prevent chemotherapy-induced nausea and vomiting. However, frequent dexamethasone administration is associated with hyperglycemia and reduced bone density.

The SPARED trial therefore evaluated patients who underwent treatment with at least 50 mg/m2 of cisplatin-based chemotherapy, were aged 20 to 74 years, had a solid malignant tumor diagnosis, an ECOG performance score of 1 or less, and had no nausea and vomiting. Participants were randomized 1:1 to arm D4 (n = 139) or arm D1 (n = 139). Patients in arm D4 received dexamethasone on days 1 through 4 and arm D1 was treated with dexamethasone on day 1. Both arms also received neurokinin-1 receptor antagonist on day 1, palonosetron on day 1, and 5 mg of olanzapine on days 1 through 4.

Web-based questionnaires were used to evaluate nausea/vomiting PRO-CTCAE and QLQ C-30 on day 0. The web-based nausea/vomiting PRO-CTCAE/CTCAE questionnaire was also completed on days 2 through 6. After discharge on days 7 and 8, the QLQ C-30 paper questionnaire was filled out by patients.

The primary end point of the trial was complete response rate in delayed phased. Secondary end points included no nausea/no vomiting rates, nausea severity, quality of life by EORTC QLQ-C30, and adverse events by CTCAE v4.0 and PRO-CTCAE.

The baseline patient characteristics were well balanced between the D4 and D1 arms; the median age was 63 years (range, 35-74) and 64 (range, 25-74), respectively. Most patients in both arms were males (68.3% vs 69.8%), had an ECOG performance status of 0 (77.0% vs 76.3%), and did not undergo concurrent radiotherapy (63.3% vs 64.7%).

Esophageal (40.3%), head and neck (23.0%), lung (18.0%), gastric (7.2%), and others (11.5%) were the primary tumors in arm D4. Comparatively, the primary tumor sites in arm D1 were esophageal (38.1%), head and neck (26.6%), lung (20.1%), gastric (4.3%), and others (10.8%).

Study authors concluded that further analyses are still warranted to better select suitable patients for dexamethasone sparing.


Iihara H, Makuuchi M, Kawaguchi T, et al. Patient-reported outcomes with dexamethasone sparing in CDDP-based chemotherapy: a randomized, placebo-controlled, phase III study (SPARED trial). Poster presented at: Multinational Association of Supportive Care in Cancer Annual Meeting; June 23-25

Related Videos
Arash Rezazadeh Kalebasty
Karyn Goodman
Reanne Booker on Factors to Consider When Discussing Palliative Radiation
Grace Choong
Ahulwalia on Targeting the Blood Brain Barrier With Novel Immunotherapies and Precision Oncology
Verina on Tackling Neurological Toxicities From CAR T-Cell Therapy
Paula Anastasia Emphasizes Importance of Genetic Testing in Selecting Maintenance
Laura Wood on the Integration of Avelumab, Erdafitinib, and Enfortumab Vedotin into Urothelial Cancer Care
Sherry Adkins Talks Primary Care Provider Communication Following CAR T-cell Therapy
Related Content
© 2023 MJH Life Sciences

All rights reserved.