ABSTRACT
Palliative care discussions offer a unique opportunity for helping patients choose end-of-life (EOL) treatments. These are among the most difficult decisions in later life, and protecting patients' ability to make these choices is one of healthcare's strongest ethical mandates. Yet, traditional approaches to advance care planning (ACP) have only been moderately successful in helping patients make decisions that lead to treatments concordant with their values. In particular, neglect of attention to the emotions that occur during consideration of the end of one's life contributes to patients' difficulty with engaging in the process and following through on decisions. To improve ACP outcomes, providers can address the patient's emotional experiences, and can use motivational interviewing as a way attend to elicit them and incorporate them into care planning. Applying personalizing emotion-attuned protocols like Conditional Medical Orders (CMO) also promotes this end.
ABSTRACT
Risk managers and ethicists monitor adherence to codes of conduct in the delivery of medical services and proactively participate with providers to create protocols that minimize the moral, ethical, and legal risks inherent in many commonly used medical protocols. "Code/no code" medical orders work well for patients at the extremes who always or never want to undergo a procedure, but they create troubling uncertainties for others by preventing them from expressly requesting procedures under some circumstances but not others. Obeying binary orders such as DNAR (Do Not Attempt Resuscitation) can allow deaths that a patient might want to delay or can expose patients to prolonged suffering they wish to avoid. These risks can be reduced by: (1) fully explaining the nature of proposed interventions and their possible beneficial and adverse effects in varying circumstances; and (2) replacing the traditional dichotomy with a continuum of options from always, through conditionally sometime, to never orders adapted to a range of situations and preferences. The Conditional Medical Orders (CMO) form summarizes patients' preferences regarding resuscitation, ventilation, and artificial hydration and nutrition (ANH) is an efficient way to increases the chance that patients will undergo only the treatments they want.
Subject(s)
Morals , Resuscitation Orders , Critical Care , Data Collection , HumansABSTRACT
BACKGROUND: Cetuximab (C), alone or with irinotecan, demonstrates activity in irinotecan-refractory colorectal cancer (CRC). Activity of 5-fluorouracil (5-FU), leucovorin (L), and bevacizumab (B), and preliminary data of cetuximab + bevacizumab, and toxicity profiles suggests that FOLF-CB (5-FU, L, C+B) may have activity with a favorable toxicity profile as first-line therapy. METHODS: Eligible patients were randomized at registration to either arm A (mFOLFOX6-B) (modified, 5-FU. L (folinic acid), oxaliplatin (O) + bevacizumab), administered days 1 and 15 of each 28-day cycle as bevacizumab 5 mg/kg, oxaliplatin 85 mg/m(2), leucovorin 400 mg/m(2), and 5-FU 400 mg/m(2) then 1200 mg/m(2)/day for 48 hours, or arm B (FOLF-CB), which included bevacizumab, leucovorin, and 5-FU as in arm A and cetuximab 400 mg/m(2) day 1 cycle 1; all other weekly cetuximab doses were 250 mg/m(2). RESULTS: Two hundred forty-seven patients (arm A/arm B 124/123) were enrolled, and 239 were treated (118/121). Twelve-month progression-free survival (PFS) was 45%/32%, objective response rates (ORR) (complete response [CR] + partial response [PR]) were 52%/41%, disease control rates (CR+PR+stable disease [SD]) were 87%/83%, and median overall survival (OS) was 21/19.5 months, respectively. Grade 3-4 neutropenia was higher in arm A (28%/7%), as was grade 3 fatigue (12%/3%), and grade 3 neuropathy (11%/< 1%), whereas acneiform rash was confined to arm B. Retrospective analysis of KRAS mutational status did not demonstrate KRAS as a meaningful determinant of activity, except in arm B patients with KRAS-mutated tumors, which resulted in inferior PFS. Patient satisfaction favored the control (mFOLFOX6-B). CONCLUSION: FOLF-CB was not superior to mFOLFOX6-B in terms of 12-month PFS and ORR, and was not more acceptable to patients. This trial supports the conclusion of other recently reported trials that concurrent cetuximab+bevacizumab should not be routinely used in metastatic CRC.