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  • American Society of Clinical Oncology (ASCO)  (24)
  • 1
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 29, No. 36 ( 2011-12-20), p. 4755-4762
    Abstract: An Institute of Medicine report recommends that patients with cancer receive a survivorship care plan (SCP). The trial objective was to determine if an SCP for breast cancer survivors improves patient-reported outcomes. Patients and Methods Women with early-stage breast cancer who completed primary treatment at least 3 months previously were eligible. Consenting patients were allocated within two strata: less than 24 months and ≥ 24 months since diagnosis. All patients were transferred to their own primary care physician (PCP) for follow-up. In addition to a discharge visit, the intervention group received an SCP, which was reviewed during a 30-minute educational session with a nurse, and their PCP received the SCP and guideline on follow-up. The primary outcome was cancer-related distress at 12 months, assessed by the Impact of Event Scale (IES). Secondary outcomes included quality of life, patient satisfaction, continuity/coordination of care, and health service measures. Results Overall, 408 survivors were enrolled through nine tertiary cancer centers. There were no differences between groups on cancer-related distress or on any of the patient-reported secondary outcomes, and there were no differences when the two strata were analyzed separately. More patients in the intervention than control group correctly identify their PCP as primarily responsible for follow-up (98.7% v 89.1%; difference, 9.6%; 95% CI, 3.9 to 15.9; P = .005). Conclusion The results do not support the hypothesis that SCPs are beneficial for improving patient-reported outcomes. Transferring follow-up to PCPs is considered an important strategy to meet the demand for scarce oncology resources. SCPs were no better than a standard discharge visit with the oncologist to facilitate transfer.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2011
    detail.hit.zdb_id: 2005181-5
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  • 2
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 32 ( 2013-11-10), p. 4038-4045
    Abstract: To report interim cosmetic and toxicity results of a multicenter randomized trial comparing accelerated partial-breast irradiation (APBI) using three-dimensional conformal external beam radiation therapy (3D-CRT) with whole-breast irradiation (WBI). Patients and Methods Women age 〉 40 years with invasive or in situ breast cancer ≤ 3 cm were randomly assigned after breast-conserving surgery to 3D-CRT APBI (38.5 Gy in 10 fractions twice daily) or WBI (42.5 Gy in 16 or 50 Gy in 25 daily fractions ± boost irradiation). The primary outcome was ipsilateral breast tumor recurrence (IBTR). Secondary outcomes were cosmesis and toxicity. Adverse cosmesis was defined as a fair or poor global cosmetic score. After a planned interim cosmetic analysis, the data, safety, and monitoring committee recommended release of results. There have been too few IBTR events to trigger an efficacy analysis. Results Between 2006 and 2011, 2,135 women were randomly assigned to 3D-CRT APBI or WBI. Median follow-up was 36 months. Adverse cosmesis at 3 years was increased among those treated with APBI compared with WBI as assessed by trained nurses (29% v 17%; P 〈 .001), by patients (26% v 18%; P = .0022), and by physicians reviewing digital photographs (35% v 17%; P 〈 .001). Grade 3 toxicities were rare in both treatment arms (1.4% v 0%), but grade 1 and 2 toxicities were increased among those who received APBI compared with WBI (P 〈 .001). Conclusion 3D-CRT APBI increased rates of adverse cosmesis and late radiation toxicity compared with standard WBI. Clinicians and patients are cautioned against the use of 3D-CRT APBI outside the context of a controlled trial.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2013
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  • 3
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 4_suppl ( 2012-02-01), p. 390-390
    Abstract: 390 Background: An increasing proportion of patients with liver CAM are undergoing hepatic resection with curative intent. Detection of occult metastastic disease is important in this setting, and PET/CT is used to identify patients with either inoperable, or limited resectable extrahepatic disease not identified with conventional imaging. We recently reported the results related to the primary objective of PETCAM, a randomized trial for patients with resectable liver CAM, where 7.6% had a change in management based on PET/CT (ASCO 2011). As a secondary objective, we examined whether patients undergoing PET/CT derived a survival benefit, as they may be considered to be better selected. Methods: PETCAM was a multicenter trial with 404 subjects randomized 2:1 to receive PET/CT or no PET/CT once they were assessed by a hepatobiliary surgeon to have resectable CAM. Subjects were followed over 4 years for overall survival (OS). As well as the intervention, we considered the SUV, Fong Score and other baseline factors as predictors for OS. Results: After a median 2.8 years of follow-up, 107 of the 404 (26%) study subjects had died. The 270 PET/CT subjects [and the 245 of these who underwent surgery] showed no statistically significant survival advantage over the 134 No PET/CT subjects [123 who underwent surgery] with a hazard ratio (HR) of 0.85, 95% confidence interval (CI): 0.57 to 1.3; p=0.41 [HR=0.81, 95% CI: 0.52 to 1.3; p=0.34]. Fong score was a strong predictor of OS for all patients (HR=1.4, 95% CI: 1.1 to 1.6), and for those who had surgery (HR=1.4, 95% CI, 1.1 to 1.7). In the PET/CT arm, SUV is strongly predictive of OS [HR per unit SUV increase =1.11, 95% CI: 1.05 to 1.18; p=0.0007. Conclusions: The addition of PET/CT had no effect on improving overall survival for patients who did or did not have hepatic resection for CAM. SUV is strongly predictive of survival for patients who had PET/CT, and Fong score is predictive of survival for all patients. The overall role of PET/CT in patients with resectable CAM appears limited and should be reevaluated in the current era of comparative effectiveness research and health care cost containment.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2012
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  • 4
    Online Resource
    Online Resource
    American Society of Clinical Oncology (ASCO) ; 2006
    In:  Journal of Clinical Oncology Vol. 24, No. 22 ( 2006-08-01), p. 3711-3712
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 24, No. 22 ( 2006-08-01), p. 3711-3712
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2006
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  • 5
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 34, No. 15_suppl ( 2016-05-20), p. 5003-5003
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2016
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  • 6
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 23, No. 6 ( 2005-02-20), p. 1192-1199
    Abstract: To determine if iridium implant (IM) and external-beam radiation therapy (EBRT) is better than standard EBRT in locally advanced prostate cancer. Methods Patients with T2 and T3 prostate cancer with no evidence of metastatic disease were randomly assigned to EBRT of 66 Gy in 33 fractions during 6.5 weeks or to IM of 35 Gy delivered to the prostate during 48 hours plus EBRT of 40 Gy in 20 fractions during 4 weeks. The primary outcome consisted of biochemical or clinical failure (BCF). BCF was defined by biochemical failure, clinical failure, or death as a result of prostate cancer. Secondary outcomes included 2-year postradiation biopsy positivity, toxicity, and survival. Results Between 1992 and 1997, 51 patients were randomly assigned to receive IM plus EBRT, and 53 patients were randomly assigned to receive EBRT alone. The median follow-up was 8.2 years. In the IM plus EBRT arm, 17 patients (29%) experienced BCF compared with 33 patients (61%) in the EBRT arm (hazard ratio, 0.42; P = .0024). Eighty-seven patients (84%) had a postradiation biopsy; 10 (24%) of 42 in the IM plus EBRT arm had biopsy positivity compared with 23 (51%) of 45 in the EBRT arm (odds ratio, 0.30; P = .015). Overall survival was 94% in the IM plus EBRT arm versus 92% in the EBRT arm. Conclusion The combination of IM plus EBRT was superior to EBRT alone for BCF and postradiation biopsy. This trial provides evidence that higher doses of radiation delivered in a shorter duration result in better local as well as biochemical control in locally advanced prostrate cancer.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2005
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  • 7
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 15_suppl ( 2012-05-20), p. 6049-6049
    Abstract: 6049 Background: The clinical utility of PET/CT in patients with suspected cancer recurrence remains unclear. The aim of this multi-center, prospective, comparative effectiveness study is to assess the impact of PET/CT on clinical management of patients with suspected cancer recurrence. Methods: Patients were eligible if cancer recurrence (non-small cell lung, breast, head and neck, ovarian, esophageal, Hodgkin’s or non-Hodgkin’s lymphoma) was clinically suspected, and if conventional imaging (e.g. X-ray, ultrasound, CT, or MRI) was non-diagnostic. As a pre-requisite to PET/CT booking, clinicians were asked at enrolment to indicate their planned management if PET/CT were not available. Patients then underwent 18 FDG-PET/CT. Clinicians were then asked to indicate their management plan based on PET/CT findings. Patients were followed up once at 3 months. The primary outcome was change in planned management after PET/CT and was assessed independently and in duplicate by external outcome adjudicators using all available source documents. Results: 101 patients (mean age 64 y, 45% male, median 1.3 y since last treatment) were enrolled from 4 centers in Ontario, Canada between April 2009 and June 2011. Distribution of tumor types was: non-small cell lung (55%), breast (19%), ovarian (10%), esophageal (6%), lymphoma (6%), head and neck (4%). 8 patients did not complete the study (non-adherence to protocol, 2; death, 5; disease progression prior to PET/CT, 1), of whom 2 did not receive PET/CT. PET/CT changed planned management in 52 (53%) patients (Table). At 3 months, planned management was carried out in 46/52 (88%) patients. Conclusions: In patients with suspected cancer recurrence, PET/CT changes planned management from non-treatment to treatment for approximately 1 in every 3 patients (“number needed to scan” = 3) and contributes importantly to clinical management. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2012
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  • 8
    Online Resource
    Online Resource
    American Society of Clinical Oncology (ASCO) ; 2018
    In:  Journal of Clinical Oncology Vol. 36, No. 3 ( 2018-01-20), p. 238-243
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 36, No. 3 ( 2018-01-20), p. 238-243
    Abstract: The 21-gene assay Oncotype Dx (Genomic Health, Redwood City, CA) test is used to aid the decision about chemotherapy in patients with hormone receptor–positive breast cancer who received endocrine therapy. Economic studies to support test adoption used decision-analytic models with assumptions and data derived from disparate sources. The objective was to evaluate whether the 21-gene assay test resulted in an overall cost expense or saving to the health system. Patients and Methods One thousand participants enrolled in a field evaluation study, were linked to population-level health system administrative databases, and were observed for 20 months. The cost for the cohort, which included the cost of the test, subsequent treatments received, and health care encounters, was determined. The cost in the absence of the test was compared with the pretest recommendation about chemotherapy from the field study for a base case and under scenarios that reflected different adjuvant chemotherapy use. Overall health system costs and incremental costs were calculated. Results The 21-gene assay resulted in a net decrease in chemotherapy use of 23%. For the base case incremental analysis, the actual overall health system cost of this cohort, including the cost of 21-gene assay, was $29.2 million compared with $26.2 million in the absence of the test—an increase of $3.1 million. For three of the four scenario analyses, the actual overall cost to the health system exceeded the estimated cost in the absence of the test. Results showed that, when at least half of the population received adjuvant chemotherapy, the cost increased to $30.2 million. Conclusion The use of real-world administrative data showed that, despite lower rates of chemotherapy use, the 21-gene assay test results in an overall incremental cost to the health care system in the short-term under most assumptions.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2018
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  • 9
    Online Resource
    Online Resource
    American Society of Clinical Oncology (ASCO) ; 2014
    In:  Journal of Oncology Practice Vol. 10, No. 2 ( 2014-03), p. e86-e92
    In: Journal of Oncology Practice, American Society of Clinical Oncology (ASCO), Vol. 10, No. 2 ( 2014-03), p. e86-e92
    Abstract: Survivorship care plans (SCPs) are recommended for patients who have completed primary treatment and are transitioning to routine follow-up care. However, SCPs may be costly, and their effectiveness is unproven. The study objective was to assess the cost effectiveness of an SCP for breast cancer survivors transitioning to routine follow-up care with their own primary care physician (PCP) using data from a recent randomized controlled trial (RCT). Methods: Resource use and utility data for 408 patients with breast cancer enrolled in the RCT comparing an SCP with standard care (no SCP) were used. The intervention group received a 30-minute educational session with a nurse and their SCP, and their PCPs received the SCP plus a full guideline on follow-up. Analysis assessed the societal costs and quality-adjusted life years (QALYs) for the intervention group and the control group over the 2-year follow-up of the RCT. Uncertainty concerning cost effectiveness was assessed through nonparametric bootstrapping and deterministic sensitivity analysis. Results: The no-SCP group had better outcomes than the SCP group: total costs per patient were lower for standard care (Canadian $698 v $765), and total QALYs were almost equivalent (1.42 for standard care v 1.41 for the SCP). The probability that the SCP was cost effective was 0.26 at a threshold value of a QALY of $50,000. A variety of sensitivity analyses did not change the conclusions of the analysis. Conclusion: This SCP would be costly to introduce and would not be a cost effective use of scarce health care resources.
    Type of Medium: Online Resource
    ISSN: 1554-7477 , 1935-469X
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2014
    detail.hit.zdb_id: 3005549-0
    detail.hit.zdb_id: 2236338-5
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  • 10
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 24, No. 6 ( 2006-02-20), p. 848-855
    Abstract: Most women with breast cancer are diagnosed at an early stage and more than 80% will be long-term survivors. Routine follow-up marks the transition from intensive treatment to survivorship. It is usual practice for routine follow-up to take place in specialist clinics. This study tested the hypothesis that follow-up by the patient's family physician is a safe and acceptable alternative to specialist follow-up. Patients and Methods A multicenter, randomized, controlled trial was conducted involving 968 patients with early-stage breast cancer who had completed adjuvant treatment, were disease free, and were between 9 and 15 months after diagnosis. Patients may have continued receiving adjuvant hormonal therapy. Patients were randomly allocated to follow-up in the cancer center according to usual practice (CC group) or follow-up from their own family physician (FP group). The primary outcome was the rate of recurrence-related serious clinical events (SCEs). The secondary outcome was health-related quality of life (HRQL). Results In the FP group, there were 54 recurrences (11.2%) and 29 deaths (6.0%). In the CC group, there were 64 recurrences (13.2%) and 30 deaths (6.2%). In the FP group, 17 patients (3.5%) compared with 18 patients (3.7%) in the CC group experienced an SCE (0.19% difference; 95% CI, −2.26% to 2.65%). No statistically significant differences (P 〈 .05) were detected between groups on any of the HRQL questionnaires. Conclusion Breast cancer patients can be offered follow-up by their family physician without concern that important recurrence-related SCEs will occur more frequently or that HRQL will be negatively affected.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2006
    detail.hit.zdb_id: 2005181-5
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