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This article describes an effective process for developing a nursing strategic plan (NSP), involving the full nursing team. A NSP should represent the voice of all nurses in a meaningful way. More than 2,000 nurses were invited to offer ideas, which were collected through both survey and in-person meetings, underwent thematic analysis, and were condensed to 41 categories, for review at a retreat. Nine NSP goals were identified and developed. Retreat participants evaluated the NSP process positively, scoring 4.77 on a 1 to 5 scale, across 8 items. [ABSTRACT FROM AUTHOR]

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Single-agent ibrutinib is active in patients with previously treated mantle cell lymphoma (MCL); however, nearly half of all patients experience treatment failure during the first year. We previously demonstrated that prolonged early G1 cell cycle arrest induced by the oral, specific CDK4/6 inhibitor palbociclib can overcome ibrutinib resistance in primary human MCL cells and MCL cell lines expressing wild-type Bruton’s tyrosine kinase (BTK). Therefore, we conducted a phase 1 trial to evaluate the dosing, safety, and preliminary activity of palbociclib plus ibrutinib in patients with previously treated mantle cell lymphoma. From August 2014 to June 2016, a total of 27 patients (21 men, 6 women) were enrolled. The maximum tolerated doses were ibrutinib 560 mg daily plus palbociclib 100 mg on days 1 to 21 of each 28-day cycle. The dose-limiting toxicity was grade 3 rash. The most common grade 3 to 4 toxicities included neutropenia (41%), thrombocytopenia (30%), hypertension (15%), febrile neutropenia (15%), and lung infection (11%). The overall and complete response rates were 67% and 37%, and with a median follow-up of 25.6 months, the 2-year progression-free survival was 59.4% and the 2-year response duration was 69.8%. A phase 2 multicenter clinical trial to further characterize efficacy is now ongoing. The current trial was registered at www.clinicaltrials.gov as #NCT02159755.

Bartlett: Merck: Research Funding; Pharmacyclics: Research Funding; Seattle Genetics: Research Funding; ADC Therapeutics: Consultancy, Research Funding; Affimed: Research Funding; Bristol-Myers Squibb: Research Funding; Genenetech: Research Funding; Gilead: Research Funding; Immune Design: Research Funding; Pfizer: Research Funding; Millenium: Research Funding; Janssen: Research Funding; Celgene: Research Funding; Forty Seven: Research Funding. Maddocks:Celgene: Membership on an entity's Board of Directors or advisory committees; Novartis: Research Funding; BMS: Research Funding; Teva: Membership on an entity's Board of Directors or advisory committees; Pharmacyclics: Membership on an entity's Board of Directors or advisory committees, Research Funding; Merck: Research Funding. Park:Rafael Pharma: Membership on an entity's Board of Directors or advisory committees; BMS: Consultancy, Research Funding; Seattle Genetics: Research Funding, Speakers Bureau; G1 Therapeutics: Consultancy; Teva: Consultancy, Research Funding; Gilead: Speakers Bureau. Ruan:Juno: Consultancy; Kite: Consultancy; Janssen: Consultancy, Honoraria; Pharmacyclics LLC, an AbbVie company: Research Funding; AstraZeneca: Consultancy, Honoraria; Seattle Genetics: Consultancy, Honoraria, Research Funding; Celgene: Consultancy, Honoraria, Research Funding. Galluzzi:Inzen: Consultancy; Luke Heller TECPR2 Foundation: Consultancy; Astra Zeneca: Consultancy; OmniSEQ: Consultancy, Membership on an entity's Board of Directors or advisory committees. Leonard:Sutro Biopharma: Consultancy; Bayer Corporation: Consultancy; AstraZeneca: Consultancy; Genentech, Inc./F. Hoffmann-La Roche Ltd: Consultancy; Bayer Corporation: Consultancy; MorphoSys: Consultancy; Karyopharm Therapeutics: Consultancy; Miltenyi: Consultancy; Akcea Therapeutics: Consultancy; Celgene: Consultancy; Epizyme, Inc: Consultancy; Merck: Consultancy; Akcea Therapeutics: Consultancy; Gilead: Consultancy; Sutro Biopharma: Consultancy; BeiGene: Consultancy; MorphoSys: Consultancy; AstraZeneca: Consultancy; Celgene: Consultancy; Epizyme, Inc: Consultancy; Karyopharm Therapeutics: Consultancy; Genentech, Inc./F. Hoffmann-La Roche Ltd: Consultancy; Nordic Nanovector: Consultancy; ADC Therapeutics: Consultancy; Sandoz: Consultancy; BeiGene: Consultancy; Sandoz: Consultancy; Gilead: Consultancy; ADC Therapeutics: Consultancy; Nordic Nanovector: Consultancy; Merck: Consultancy; Miltenyi: Consultancy. Martin:Janssen: Consultancy; Teneobio: Consultancy; Karyopharm: Consultancy; Celgene: Consultancy; I-MAB: Consultancy; Sandoz: Consultancy.Palbociclib is a CDK4/6 inhibitor FDA-approved for breat cancer treatment. It was used off-label in combination with ibrutinib in a phase I clinical trial in patients with relapsed/refractory mantle cell lymphoma.

Mantle cell lymphoma (MCL) is incurable due to the development of drug resistance. MCL cells proliferate without constraint on disease progression, fueled by aberrant cyclin D1 expression due to (11;14)(q13;q32) chromosomal translocation and dysregulation of CDK4 (CDK6 is silenced) that accelerate cell cycle progression through G1. Previously, we demonstrated that selective inhibition of CDK4/6 with palbociclib leads to prolonged early G1 arrest that sensitizes MCL cells to partner drugs including the BTK inhibitor ibrutinib. In our phase I clinical trial of palbociclib + ibrutinib (PALIBR) in recurrent MCL, complete response (CR) was achieved in 10/28 patients with only 5/19 responding patients progressing in 5 years. CDK4/6 inhibition thus appears to prolong and deepen the clinical response to ibrutinib.