Knowing one's poor prognosis and confronting one's impending death without full acceptance and adequate professional psycho-spiritual support may harm more than benefit terminally ill cancer patients' psychological state, existential well-being, and QOL. These findings highlight the importance of tailoring psycho-spiritual support to cancer patients' psychological and existential needs when prognostic information is disclosed.
387 Background: This Phase 1 study (NCT01938612) evaluated D (anti-PD-L1 mAb) and T (anti-CTLA-4 mAb) in Asian pts, in whom optimal dosing of D and T is undetermined. No dose-limiting toxicities were observed, and durable responses were seen in a dose escalation phase evaluating various D doses and regimens in Japanese pts (Iguchi, ASCO 2015). The study was subsequently expanded to larger cohorts of Asian pts with advanced solid tumors including BTC. Methods: Two regimens were selected for the expansion phase: D monotherapy (10 mg/kg q2w) and D+T (D 20 mg/kg + T 1.0 mg/kg q4w). One cohort of pts with advanced BTC was enrolled to receive D monotherapy followed by a separate cohort that received D+T with additional pts enrolled if efficacy was observed. Safety, response, and survival endpoints were based on investigator assessment. Results: Pts were enrolled to D (N = 42) or D+T (N = 65). Median age was 64 years for the D cohort and 62 years for the D+T cohort, the majority were male, and ECOG PS was 0 or 1: 64% and 36% for pts in the D cohort and 49% and 51% for pts in the D+T cohort, respectively. Median number of prior chemotherapy regimens was 2 for both cohorts. Treatment-related adverse events (trAE) of any grade occurred in 64% and 82% of pts in the D and D+T cohorts. Grade ≥ 3 trAEs occurred in 19% and 23% of pts in the D and D+T cohorts. trAEs led to discontinuation in 2 pts in the D cohort and 5 pts in the D+T cohort. A death due to trAE (drug-induced liver injury) was reported in the D+T cohort, none in the D cohort. In the D cohort, 2 pts had a partial response (PR) and 7 pts had a PR in the D+T cohort; disease control rate at 12 weeks was 16.7% and 32.2%, respectively. Median duration of response for the D cohort was 9.7 months and 8.5 months for the D+T cohort. Median overall survival was 8.1 (95% CI, 5.6-10.1) months and 10.1 (95% CI, 6.2-11.4) months for the D and D+T cohorts, respectively. Conclusions: Both D monotherapy and D+T combination therapy were tolerable for Asian pts with BTC, and no unexpected toxicities were observed with either regimen. Promising clinical benefit was observed with both D and D+T therapy. This study provides valuable information regarding these therapeutic regimens for future studies in pts with BTC. Clinical trial information: NCT01938612.
Dexamethasone is likely to play a role in the etiology of hiccups in patients receiving cisplatin-based regimens. Two hundred seventy-seven patients received three doses of ondansetron 8mg intravenously (IV) at 4hour intervals plus dexamethasone 20mg IV from the start of chemotherapy, followed by dexamethasone 5mg IV every 12hours, until chemotherapy was complete. Hiccups were observed in 114 (41.2%) patients, of whom 97.4% were men. Nausea and vomiting showed inverse correlations with hiccups (P < 0.0001 and P = 0.001, respectively). In 73 patients who experienced hiccups but lacked nausea/vomiting (H+N/V-), we discontinued dexamethasone in subsequent cycles. Sixty-six patients (90.4%) ceased hiccuping, but complete protection rates of nausea and vomiting decreased to 63% and 74%, respectively. For patients who experienced both hiccups and nausea/vomiting, the onset of nausea/vomiting usually was delayed to Day 3 or 4 and began after the cessation of hiccups. We conclude that cisplatin-related hiccups are predominant in males, dexamethasone-induced, and associated with protection against nausea/vomiting.
Background: This study was conducted to examine whether a longitudinal advance care planning (ACP) intervention facilitates concordance between the preferred and received life-sustaining treatments (LSTs) of terminally ill patients with cancer and improves quality of life (QoL), anxiety symptoms, and depressive symptoms during the dying process. Patients and Methods: Of 795 terminally ill patients with cancer from a medical center in Taiwan, 460 were recruited and randomly assigned 1:1 to the experimental and control arms. The experimental arm received an interactive ACP intervention tailored to participants’ readiness to engage in this process. The control arm received symptom management education. Group allocation was concealed, data collectors were blinded, and treatment fidelity was monitored. Outcome measures included 6 preferred and received LSTs, QoL, anxiety symptoms, and depressive symptoms. Intervention effectiveness was evaluated by intention-to-treat analysis. Results: Participants providing data had died through December 2017. The 2 study arms did not differ significantly in concordance between the 6 preferred and received LSTs examined (odds ratios, 0.966 [95% CI, 0.653–1.428] and 1.107 [95% CI, 0.690–1.775]). Participants who received the ACP intervention had significantly fewer anxiety symptoms (β, −0.583; 95% CI, −0.977 to −0.189; P= .004) and depressive symptoms (β, −0.533; 95% CI, −1.036 to −0.030; P= .038) compared with those in the control arm, but QoL did not differ. Conclusions: Our ACP intervention facilitated participants’ psychological adjustment to the end-of-life (EoL) care decision-making process, but neither improved QoL nor facilitated EoL care honoring their wishes. The inability of our intervention to improve concordance may have been due to the family power to override patients’ wishes in deeply Confucian doctrine–influenced societies such as Taiwan. Nevertheless, our findings reassure healthcare professionals that such an ACP intervention does not harm but improves the psychological well-being of terminally ill patients with cancer, thereby encouraging physicians to discuss EoL care preferences with patients and involve family caregivers in EoL care decision-making to eventually lead to patient value–concordant EoL cancer care.
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