Dexamethasone sparting with cisplatin-based chemotherapy has no significant impact on QoL

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Dexamethasone sparing in cisplatin-based chemotherapy did not affect global health outcomes, although it did worsen nausea and anorexia, according to patient-reported results from the Phase 3 SPARED study (UMIN000032269) published at the Multinational Association of Supportive Care in Cancer 2022 was presented Annual meeting.

Global health status, as assessed by the EORTC QLQ-C30 questionnaire, was slightly higher in the arm receiving dexamethasone on Day 1 only (Arm D1) than in the arm receiving dexamethasone on Days 1 through 4 (Arm D4 ;Arm D4; P = 0.38). Patients in the two arms also scored similarly on symptom scales related to fatigue (P = 0.17), pain (P = .19), shortness of breath (P = 0.81), insomnia (P = 0.41), diarrhea (P = .26) and financial difficulties (P = 0.96). In addition, the two arms were close together on the functional scales that evaluated emotionally (P = .75), cognitive (P = .13) and social (P = .42) well-being.

However, appetite loss according to the EORTC QLQ-C30 scale was worse in arm D1 compared to arm D4 (P P = 0.04). In patients with a Nausea Numeric Rating Scale (NRS) score of at least 1, overall nausea severity favored arm D1 (P = 0.04). In patients with significant nausea (NRS > 3), overall rates were more closely matched between the two arms (P = 0.29).

The overall no-vomiting rate was very similar between the two arms: 94.93% and 94.12% (P = 0.77).

Dexamethasone is a steroid that is commonly given to patients about to undergo highly emetogenic chemotherapy to prevent chemotherapy-induced nausea and vomiting. However, frequent administration of dexamethasone is associated with hyperglycemia and reduced bone mineral density.

The SPARED study therefore evaluated patients who received treatment with at least 50 mg/m2 of cisplatin-based chemotherapy, were aged 20 to 74 years, had a solid malignancy diagnosis, had an ECOG performance score of 1 or less and no nausea and nausea had 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 to 4 and arm D1 received dexamethasone on day 1. Both arms also received a neurokinin-1 receptor antagonist on day 1, palonosetron on day 1, and olanzapine 5 mg on days 1 through 4.

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

The primary endpoint of the study was the complete response rate in the delayed phase. Secondary endpoints included no nausea/vomiting, nausea severity, quality of life by EORTC QLQ-C30, and adverse events by CTCAE v4.0 and PRO-CTCAE.

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

Esophageal (40.3%), head and neck (23.0%), lung (18.0%), stomach (7.2%) and other (11.5%) were the primary tumors in arm D4. In comparison, the primary tumor sites in arm D1 were esophagus (38.1%), head and neck (26.6%), lung (20.1%), stomach (4.3%), and other (10.8% ).

The study authors concluded that further analysis is still warranted to better select suitable patients for dexamethasone sparing.

Relation

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

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