Colorectal cancer survivorship care plans: Variations in documentation and posttreatment surveillance recommendations.

BACKGROUND: Survivorship care plans (SCP) should outline pertinent information about cancer treatment and follow-up. METHODS: We descriptively analyzed the content of 74 colorectal cancer SCPs completed as part of a randomized, controlled trial of SCPs at an academic and community cancer center. Surveillance recommendations were compared with American Cancer Society, American Society of Clinical Oncology and National Comprehensive Cancer Network guidelines. RESULTS: SCP information provided in >80% of the plans included participant age, cancer diagnosis, details, and side-effects of treatment (surgery, chemotherapy, radiation) and health promotion recommendations. SCP content documented less frequently included predisposing conditions, genetic counseling/testing information and staging. Posttreatment surveillance recommendations were documented in >90% SCPs. For stage 2-3 cancer, rates of guideline concordant recommendations were 100% for colonoscopy surveillance (Year 1 only), 87% for imaging surveillance, 65% for carcinoembryonic antigen surveillance, and 33% for follow-up visits. Excluding colonoscopy, >15 unique recommendations were listed for each modality across stages and sites, with more variation at the academic site. CONCLUSIONS: SCPs consistently recorded information about cancer diagnosis and treatment but omitted critical information about cancer-specific details denoting risk. Surveillance recommendations varied considerably between cancer centers. Future work to improve the consistency of surveillance recommendations documented in SCPs may be needed.

Evaluating potential overuse of surveillance care in cancer survivors.

BACKGROUND: Survivorship care plans (SCPs) communicate cancer-related information from oncology providers to patients and primary care providers. SCPs may limit overuse testing by specifying necessary follow-up care. From a randomized, controlled trial of SCP delivery, we examined whether cancer-related tests not specified in SCPs, but conducted after SCP receipt, were appropriate or consistent with overuse. METHODS: Survivors of breast, colorectal, or prostate cancer treated at urban-academic or rural-community health systems were randomized to one of three SCP delivery arms. Tests during 18 months after SCP receipt were classified as consistent with overuse if they were (1) not included in SCPs and (2) on a guideline-based predetermined list of "not recommended surveillance." After chart abstraction, physicians performed review and adjudication of potential overuse. Descriptive analyses were conducted of tests consistent with overuse. Negative binomial regression models determined if testing consistent with overuse differed across study arms. RESULTS: Among 316 patients (137 breast, 67 colorectal, 112 prostate), 140 individual tests were identified as potential overuse. Upon review, 98 were deemed to be consistent with overuse: 78 tumor markers and 20 imaging tests. The majority of overuse testing was breast cancer-related (95%). Across sites, 27 patients (9%) received ≥1 test consistent with overuse; most were breast cancer patients (22/27). Exploratory analyses of overuse test frequency by study arm showed no significant difference. CONCLUSIONS: This analysis identified practice patterns consistent with overuse of surveillance testing and can inform efforts to improve guideline-concordant care. Future interventions may include individual practice patterns and provider education.

Implementing survivorship care planning in two contrasting health systems: lessons learned from a randomized controlled trial.

OBJECTIVE: Survivorship care plans (SCPs) are recommended to promote appropriate follow-up care, but implementation has been limited. We conducted a randomized controlled trial comparing three SCP delivery models in two health systems. We utilize mixed methods to compare the feasibility and participants' perceived value of the three models. METHODS: Patients completing treatment for stage I-III breast, prostate, or colorectal cancer from one urban-academic and one rural community cancer center were randomized to (1) mailed SCP, (2) SCP delivered during an in-person survivorship visit, or (3) SCP delivered during an in-person survivorship visit plus 6-month follow-up. Clinics had flexibility in intervention implementation. Quantitative data summarize intervention fidelity and protocol deviations. Qualitative interview data provide patients' perspectives on feasibility and intervention value. RESULTS: Of 475 eligible participants approached, 378 (79%) were randomized. Of 345 SCPs delivered, 265 (76.8%) were by protocol. Protocol deviations were more common at the urban-academic center. In post-study qualitative interviews, participants recalled little about the SCP document or visit(s). SCPs were valued for information and care coordination, although their static nature was limiting, and sometimes SCP information differed from that provided elsewhere. Visits were opportunities for care and reassurance, but time and distance to the clinic were barriers. CONCLUSIONS: SCP provision was challenging. Patients were interested in SCP, but not necessarily additional survivorship visits, particularly at the urban-academic hospital. IMPLICATIONS FOR CANCER SURVIVORS: These findings suggest that patients value careful consideration of health care needs during the transition out of treatment; SCP documents are one element of this. For many patients, models without additional visits and dynamic SCPs may be preferred.

Simplifying Survivorship Care Planning: A Randomized Controlled Trial Comparing 3 Care Plan Delivery Approaches.

BACKGROUND: Survivorship care plans seek to improve the transition to survivorship, but the required resources present implementation barriers. This randomized controlled trial aimed to identify the simplest, most effective approach for survivorship care planning. METHODS: Stage 1-3 breast, colorectal, and prostate cancer patients aged 21 years or older completing treatment were recruited from an urban-academic and rural-community cancer center. Participants were randomly assigned, stratified by recruitment site and cancer type 1:1:1 to a mailed plan, plan delivered during a 1-time transition visit, or plan delivered during a transition visit plus 6-month follow-up visit. Health service use data were collected from participants and medical records for 18 months. The primary outcome, receipt of all plan-recommended care, was compared across intervention arms using logistic regression adjusting for cancer type and recruitment site, with P less than .05 considered statistically significant. RESULTS: Of 378 participants randomly assigned, 159 (42.1%) were breast, 142 (37.6%) prostate, and 77 (20.4%) colorectal cancer survivors; 207 (54.8%) from the academic site and 171 (45.2%) from the community site; 316 were analyzable for the primary outcome. There was no difference across arms in the proportion of participants receiving all plan-recommended care: 45.2% mail, 50.5% 1-visit, 42.7% 2-visit (2-sided P = .60). Adherence by cancer type for mail, 1-visit, and 2-visit, respectively, was 52.2%, 53.3%, and 40.0% for breast cancer; 48.6%, 64.1%, and 57.1% for prostate cancer; and 23.8%, 19.0%, and 26.1% for colorectal cancer. There were no statistically significant interactions by recruitment site or cancer type. CONCLUSIONS: This study did not find differences in receipt of recommended follow-up care by plan delivery approach. Feasibility and other factors may determine the best approach for survivorship care planning.

The MEK inhibitor selumetinib reduces spinal neurofibroma burden in patients with NF1 and plexiform neurofibromas.

BACKGROUND: Spinal neurofibromas (SNFs) in neurofibromatosis type 1 (NF1) can cause progressive spinal cord compression and neurological dysfunction. The MEK inhibitor selumetinib shrinks the majority of plexiform neurofibromas (PNs) in patients with NF1. We assessed the effect of selumetinib on SNF. METHODS: Pediatric and adult patients with NF1 and inoperable PN participating in phase 2 studies of selumetinib for PN were included in this analysis if they had SNF and serial spine magnetic resonance imaging (MRI). Selumetinib was administered orally at the recommended dose of 25 mg/m2/dose twice daily (max 50 mg b.i.d.; 1 cycle = 28 days). We qualitatively assessed the effect of selumetinib on SNF-related spinal canal distortion, cerebrospinal fluid distribution, and spinal cord deformity on MRI. RESULTS: Twenty-four patients (18 male), median age 16.9 years (range, 6.2-60.3), had SNF, 22 of which were associated with the same nerves as the target PN assessed on the clinical trial. Twenty patients had spinal cord deformity. Twenty-three patients completed at least 12 treatment cycles to date. Eighteen patients showed subtle to a marked improvement in SNF burden, 5 remained stable, and no worsening was observed during treatment. CONCLUSIONS: This is the first study describing the effect of selumetinib on SNF. Of 24 patients, 18 exhibited some improvement of SNF burden on imaging. These findings suggest that selumetinib may prevent the worsening of cord compression, potentially reducing the need for surgical interventions in select patients or benefitting patients who do not have a surgical option. Prospective evaluation of the clinical benefit of selumetinib for SNF is warranted.

Multisite Evaluation of a Custom Energy-Storing Carbon Fiber Orthosis for Patients with Residual Disability After Lower-Limb Trauma.

BACKGROUND: The Intrepid Dynamic Exoskeletal Orthosis (IDEO) is a custom energy-storing carbon fiber ankle-foot orthosis developed for lower-extremity trauma patients. Studies conducted at the military treatment facility where the IDEO was developed demonstrated benefits of the IDEO when used with the Return to Run Physical Therapy (RTR PT) program. The current study was designed to determine if results could be replicated at other military treatment facilities and to examine whether early performance gains in patient-reported functional outcomes remained at 12 months. METHODS: Study participants included service members who had functional deficits that interfered with daily activities at least 1 year after a traumatic unilateral lower-extremity injury at or below the knee. Participants were evaluated before receiving the IDEO, immediately following completion of RTR PT, and at 6 and 12 months. Agility, strength/power, and speed were assessed using well-established performance tests. Self-reported function was measured using the Short Musculoskeletal Function Assessment (SMFA). The Orthotics and Prosthetics Users' Survey was administered to assess satisfaction with the IDEO. Of 87 participants with complete baseline data, 6 did not complete any physical therapy and were excluded from the analysis. Follow-up rates immediately following completion of the RTR PT and at 6 and 12 months were 88%, 75%, and 79%, respectively. RESULTS: Compared with baseline, improvement at completion of RTR PT was observed in all but 1 performance test. SMFA scores for all domains except hand and arm function were lower (improved function) at 6 and 12 months. Satisfaction with the IDEO was high following completion of RTR PT, with some attenuation at the time of follow-up. CONCLUSIONS: This study adds to the evidence supporting the efficacy of the IDEO coupled with RTR PT. However, despite improvement in both performance and self-reported functioning, deficits persist compared with population norms. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

A Prospective Randomized Trial to Assess Oral Versus Intravenous Antibiotics for the Treatment of Postoperative Wound Infection After Extremity Fractures (POvIV Study).

Patients surgically treated for infection after extremity fractures are typically discharged with a 6- to 12-week antibiotic regimen. Intravenous (IV) antibiotics are associated with significant cost and potential complications of deep vein thrombosis, line clotting, and sepsis. Many of the pathogens that cause musculoskeletal infection have both oral (PO) and IV antibiotic options with adequate bioavailability and antibacterial effect, yet IV antibiotics remain the standard of care absent evidence that PO options are clinically as efficacious. The POvIV study is a prospective, multicenter, randomized trial to compare PO with IV antibiotic therapy in patients with postoperative wound infections after extremity fractures. Patients between the ages of 18 and 84 who have a culture-positive surgical site infection after internal fixation for fracture repair or arthrodesis are approached for this study, and if they provide consent, are randomly assigned to receive either PO or IV antibiotics. Antibiotic selection is based on culture and sensitivity results. Randomization determines the route of administration. Patients are followed for 1 year after study enrollment. This study will be the largest prospective randomized trial to evaluate the safety and effectiveness of PO antibiotic use for treatment of postoperative wound infections. Results will inform clinician decisions on antibiotic delivery in patients with postoperative wound infections.

Patient Response to an Integrated Orthotic and Rehabilitation Initiative for Traumatic Injuries: The PRIORITI-MTF Study.

Although limb salvage is now possible for many high-energy open fractures and crush injuries to the distal tibia, ankle, hindfoot, and midfoot, orthotic options are limited. The Intrepid Dynamic Exoskeletal Orthosis (IDEO) is a custom, energy-storing carbon fiber orthosis developed for trauma patients undergoing limb salvage. The IDEO differs from other orthoses in that it allows patients with ankle weakness to have more normal ankle biomechanics and increased ankle power. This article describes the design of a study to evaluate the effectiveness of the IDEO when delivered together with a high-intensity, sports medicine-based approach to rehabilitation. It builds on earlier studies by testing the program at military treatment facilities beyond the Brooke Army Medical Center and the Center for the Intrepid where the device was developed. The PRIORITI-MTF study is a multicenter before-after program evaluation where participants at least 1 year out from a traumatic lower extremity injury serve as their own controls. Participants are evaluated before receiving the IDEO, immediately after 4 weeks of physical therapy with the IDEO and at 6 and 12 months after the completion of physical therapy. Primary outcomes include functional performance, measured using well-validated assessments of speed, agility, power, and postural stability and self-reported functioning using the Short Musculoskeletal Function Assessment (SMFA) and the Veterans Health Survey (VR-12). Secondary outcomes include pain, depression, posttraumatic stress, and satisfaction with the IDEO.

Phase 2 study of cryptophycin 52 (LY355703) in patients previously treated with platinum based chemotherapy for advanced non-small cell lung cancer.

BACKGROUND: Cryptophycin 52 is a novel antitubulin drug with in vitro and in vivo activity in non-small cell lung cancer. Based upon promising Phase 1 data, a multicenter trial was performed to evaluate the drug in previously treated non-small cell lung cancer (NSCLC). METHODS: Patients with Stage IIIb (pleural effusion) or Stage IV NSCLC and performance status 0-1 with adequate organ function who had received at least one and no more than two prior chemotherapy regimens (one of which must have contained a platinum agent) were eligible. Cryptophycin 52 was administered at a dose of 1.5 mg/m(2) day 1 and 8 every 3 weeks. Patients were reassessed every two cycles. RESULTS: Twenty-six patients were enrolled of whom 25 are evaluable for toxicity and response. There were no responders, toxicity was predominantly neurologic in the form of peripheral neuropathy and constipation. After the first 12 patients were enrolled, the dose was lowered to 1.125 mg/m(2) day 1 and 8. Toxicity was substantially reduced with this maneuver. Median survival was 4.1 months. The median number of cycles was two, however ten patients received four or more courses of therapy. CONCLUSION: Cryptophycin 52 failed to produce measurable responses utilizing this schedule. In 40% of patients there was evidence of disease stabilization. Toxicity at 1.5 mg/m(2) was unacceptable. Since activity and toxicity may be dose and schedule dependent, other schedules of cryptophycin 52 should be considered.

Induction of MAGE-A3 and HPV-16 immunity by Trojan vaccines in patients with head and neck carcinoma.

BACKGROUND: We performed a pilot study using Trojan vaccines in patients with advanced squamous cell carcinoma of the head and neck (SCCHN). These vaccines are composed of HLA-I and HLA-II restricted melanoma antigen E (MAGE)-A3 or human papillomavirus (HPV)-16 derived peptides, joined by furin-cleavable linkers, and linked to a "penetrin" peptide sequence derived from HIV-TAT. Thirty-one patients with SCCHN were screened for the trial and 5 were enrolled. METHODS: Enrolled patients were treated with 300 µg of Trojan peptide supplemented with Montanide and granulocyte-macrophage colony-stimulating factor (GM-CSF) at 4-week intervals for up to 4 injections. RESULTS: Following vaccination, peripheral blood mononuclear cells (PBMCs) from 4 of 5 patients recognized both the full Trojan constructs and constituent HLA-II peptides, whereas responses to HLA-I restricted peptides were less pronounced. CONCLUSION: This treatment regimen seems to have acceptable toxicity and elicits measurable systemic immune responses against HLA-II restricted epitopes in a subset of patients with advanced SCCHN.