IMPROVEMENT OF QUALITY OF LIFE BY G-CSF PROPHYLAXIS IN HIGH RISK PATIENTS WITH COLORECTAL CANCER SURGERY- RESULTS OF A RANDOMIZED

203 Background: Malnutrition is very common in patients receiving radiation therapy. This can result in significant weight loss, decreased functioning, depression, increased mortality, and dramatic declines in quality of life during and after treatment. Targeting patients at risk with nutritional counseling and progressive intervention can have important clinical implications. Methods: A total of 106 patients at a hospital-based cancer center getting radiation for a wide spectrum of cancers (breast, lung, gastrointestinal, genitourinary, and other types) were evaluated for individualized nutritional counseling and education. Patients with identified risk factors were deemed to be at high risk by nursing staff if meeting pre-specified criteria for weight loss ( > 2.5%), body mass index < 18.5%, and/or gastrointestinal symptoms (poor appetite, diarrhea, or constipation affecting quality of life). After high risk patients were identified by a nursing staff triage questionnaire, an automatic computer generated referral was made to the nutritionist. Results: Prior to the institution of this protocol, 13.7% of patients getting radiation therapy were noted to be at high risk and not receiving any nutritional intervention during their course of radiotherapy. However, after the initiation of adequate screening by nursing staff triggering a nutrition referral, the percentage of high risk patients without an associated nutrition consult declined to 1.1%. Conclusions: This study conveys important information for having a systemic screening process in place to identify those at risk for progressive malnutrition while getting radiotherapy for a broad spectrum of tumor types.

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TCT-800: Quality Of Life Changes In High Risk Patients after Percutaneous Mitral Valve Repair with Mitraclip

Journal of the American College of Cardiology ◽

10.1016/j.jacc.2011.10.816 ◽

2011 ◽

Vol 58 (20) ◽

pp. B213

Keyword(s):

Quality Of Life ◽

High Risk ◽

Mitral Valve ◽

Mitral Valve Repair ◽

Life Changes ◽

Valve Repair ◽

High Risk Patients ◽

Percutaneous Mitral Valve Repair ◽

Risk Patients

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CapRI: Final results of the open-label, multicenter, randomized phase III trial of adjuvant chemoradiation plus interferon-α2b (CRI) versus 5-FU alone for patients with resected pancreatic adenocarcinoma (PAC).

Journal of Clinical Oncology ◽

10.1200/jco.2010.28.18_suppl.lba4012 ◽

2010 ◽

Vol 28 (18_suppl) ◽

pp. LBA4012-LBA4012 ◽

Cited By ~ 10

Author(s):

A. Marten ◽

J. Schmidt ◽

J. Debus ◽

S. Harig ◽

K. Lindel ◽

...

Keyword(s):

Quality Of Life ◽

Overall Survival ◽

High Risk ◽

Bolus Injection ◽

Phase Iii ◽

External Beam Radiation ◽

High Risk Patients ◽

Significant Difference ◽

Risk Patients

LBA4012 Background:Adjuvant chemomonotherapy in PAC results in five-year survival of 21% with median overall survival (mOS) of 23 months. Phase II trials evaluating adjuvant CRI showed promising results (mOS 27-44 months). Methods: Patients with an R0/R1 resection for PAC were randomized <12 weeks of surgery to receive either 5-Fluorouracil (200mg/m2/day, CI); Cisplatin (weekly 30mg/m2) and 3 million units IFN-α (three times a week) for 5.5 weeks combined with external beam radiation (50.4Gy in 28 fractions) followed by two more cycles of continuous 5-FU or 5FU/FA (FA, 20 mg/m2, iv bolus injection followed by 5-FU, 425 mg/m2, iv bolus injection given 1-5d every 28 days) for 6 months. Patients treated with CRI were challenged prior to therapy with a single dose of IFN-α. The primary outcome measure was overall survival; the secondary measures were toxicity, progression free survival and quality of life. 110 patients were calculated to detect a difference in hazard on level α= 0.05 and with a power of 80%. Results: 110 patients from five centers in Germany and Italy were randomized from July 2004 and December 2007. Median (range) age was 63 (33-77) years; 60 (57%) were men. 104 (95%) were T3 tumors, 87 (79%) were node positive and 43 (39%) were R1 resections, and 33 (30%) were poorly differentiated tumors. Grade 3 or 4 toxicity (mainly neutropenia) was observed in 68% of CRI and 16% of 5FU/FA (mainly diarrhea). Side effects during the multimodular cycle 1 were manageable and patients recovered completely. There was no difference in quality of life between the treatment groups. Final analysis was carried out on an intention to treat basis with a minimum of 2 years follow-up. Median survival of patients treated with 5FU/FA was 28.5 [95% CI: 19.5, 38.6] months and for patients treated with CRI this was 32.1 [95% CI: 22.8, 42.2] months. Although survival curves are clearly separated the log-rank analysis revealed no statistically significant difference in survival estimates. There was a clear trend towards better response for high risk patients (R1, start of treatment > 8 weeks after surgery; p=0.11). CRI reduced the risk of local recurrence (29.3% vs. 55.6%; p=0.014). Pre-planned testing for predictive markers showed that patients treated with CRI who responded to single IFN-α challenge with a decrease in T helper cells and especially regulatory T cells or with a pronounced increase in NK cell mediated cytotoxicity had a significantly longer survival. Conclusions: This is the highest ever reported mOS for adjuvant PAC in a randomized trial. Unfortunately, this underpowered trial was not able to address the significance of CRI in PAC satisfactorily. There is evidence that especially high risk patients benefit from CRI; local control improved significantly. A strong immune response to a single IFN-α challenge is significantly associated with a good outcome. Confirmatory trials are needed. [Table: see text]

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