Quality of Life in Advanced Prostate Cancer: Results of a Randomized Therapeutic Trial

Moinpour, CM; Mj, Savage; Troxel, Andrea B.; Lc, Lovato; Eisenberger, Mario A.; Rw, Veith; Higgins, Betsy; Skeel, Roland T.; Yee, Mon Oo; Ba, Blumenstein; Crawford, E. David; Fl, Meyskens

doi:10.1093/jnci/90.20.1537

Cited by 144 publications

(51 citation statements)

References 39 publications

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“…The fact that we did not find major differences in our data between the results from models assuming MAR and MNAR could be very well explained by the fact that in our study morbidity and mortality were low and the percentage of data missing was at most moderate. A number of recent studies on quality of life in patients with early-stage Hodgkin's disease [13] and non-small-cell lung cancer [14] with comparable or even higher degree of missingness also reported similar results under MAR and MNAR. Given this fact, it is all the more striking that the estimates obtained from the available cases analysis were so different.…”

Section: Discussionmentioning

confidence: 58%

Missing forms and dropout in the TME quality of life substudy

Putter

Marijnen²,

Kranenbarg³

et al. 2005

Qual Life Res

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Objective: Missing forms may pose problems in health related quality of life (QOL) studies, because the absence of a QOL measure may be related to the patient's health and hence to the patient's QOL itself. Studying patterns of missingness, dropout, and the possible impact of missing data on QOL measures is an important step in reporting outcomes of QOL studies. We study patterns of dropout and evaluate the impact of missing forms in the TME QOL substudy. Methods: Patients with rectal cancer, randomized to receive either radiotherapy plus total mesorectal excision (TME) or TME only were included in the TME trial. QOL was evaluated in 1302 Dutch patients, before treatment, and 3, 6, 12, 18 and 24 months after surgery. Here only the visual analogue score (VAS) was studied. Results: At baseline, differences between VAS scores were found with respect to whether the QOL forms were dated before or after radiotherapy and surgery. Differences were small between different statistical methods accounting for dropout; only a crosssectional analysis gave biased results. Conclusion: The results of the sensitivity analysis indicated that a linear mixed model analysis is a reliable and attractive approach for this study.

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Section: Discussionmentioning

confidence: 58%

Missing forms and dropout in the TME quality of life substudy

Putter

Marijnen²,

Kranenbarg³

et al. 2005

Qual Life Res

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“…[15][16][17][18][19][20][21][22][23] Using these references, [15][16][17][18][19][20][21][22][23] the composite value for the incidence of side effects due to short-term therapy was estimated to be 0.20. Because precise estimates for individual toxicities are not provided in any particular reference, this value was obtained by doubling the approximate hormone withdrawal rate, as hormones usually were withdrawn when side effects were intolerable.…”

Section: Adjustment For Side Effects and Relative Importance Of Survimentioning

confidence: 99%

“…Prolonging the duration of hormone therapy increases the risk of each of the side effects listed above, particularly fatigue, osteoporosis, gynecomastia, and sexual side effects. [15][16][17][18][19][20][21][22][23] Based on these references, the composite value for the incidence of side effects of long-term hormone therapy was estimated to be 0.60, a value that also was calculated by doubling the approximate withdrawal rate. Although the authors recognize that these incidence values are approximate and somewhat arbitrary, the model that has been developed is far less dependent on the incidence of side effects than on the detriment to quality of life that results from these side effects.…”

Section: Adjustment For Side Effects and Relative Importance Of Survimentioning

confidence: 99%

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Hormone therapy adjuvant to external beam radiotherapy for locally advanced prostate carcinoma

Jani

Kao

Hellman

2003

Cancer

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BACKGROUNDHormone therapy commonly is used to treat metastatic, locally advanced, and localized prostate carcinoma. The objective of the current investigation was to determine, using the number‐needed‐to‐treat (NNT) method, the effect of using hormone therapy to treat locally advanced disease, with consideration given to both the complications and the known advantages associated with hormone therapy.METHODSA literature review was performed to determine 1) the absolute benefit, based on available clinical endpoints, associated with the addition of hormone therapy to external beam radiotherapy for locally advanced prostate carcinoma; 2) the incidence of side effects of short‐term and long‐term hormone therapy; and 3) the stepwise progression from biochemical failure to death. A model was constructed to estimate the complication/utility‐adjusted survival detriment resulting from the side effects of short‐term (≤ 6 months) and long‐term (> 6 months) hormone therapy, and the absolute/unadjusted and complication‐adjusted NNTs for the addition of short‐term and long‐term hormone therapy were computed. In all cases, the magnitudes and signs of the NNTs obtained were used to gauge the effect of hormone therapy.RESULTSThe unadjusted NNTs were positive and in most cases had relatively small magnitudes (the greater the NNT, the smaller the benefit) for both short‐term and long‐term hormone therapy; these results were expected, and they suggested that there is a strong benefit associated with the use of hormones adjuvant to radiotherapy for locally advanced disease. Adjusted NNTs remained positive and had relatively small magnitudes even after the introduction into the analysis of complications of short‐term and long‐term hormone therapy. This finding, although weak with respect to the effect of short‐term hormone therapy on cause‐specific survival, remained robust over the range of values for utility impairment expected from short‐term and long‐term hormone therapy.CONCLUSIONSThe benefits of short‐term and long‐term hormone therapy for locally advanced prostate carcinoma appear to be significant and to outweigh the associated side effects. Long‐term therapy appears to be better than short‐term therapy in terms of virtually all endpoints studied, even when the increased incidence of side effects is considered. The current investigation was successful in the use of the complication‐adjusted NNT method for oncologic and radiotherapeutic scenarios in which the results of randomized trials could be summarized, adjusted for treatment toxicity, and individualized to a given patient. Cancer 2003. © 2003 American Cancer Society.

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“…It could be argued that employing an antiandrogen such as bicalutamide, which is better tolerated, might result in a better quality of life. 31 Rosendahl et al 32 tried to assess the various quality of life domains using utility scores. In comparing MAB with orchiectomy, the quality of life adjusted survival rate was 5.2 months greater with MAB.…”

Section: Quality Of Life and Prognostic Factorsmentioning

confidence: 99%

Maximum androgen blockade: a case study report

Newling

2000

Prostate Cancer Prostatic Dis

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Quality of Life in Advanced Prostate Cancer: Results of a Randomized Therapeutic Trial

Cited by 144 publications

References 39 publications

Missing forms and dropout in the TME quality of life substudy

Missing forms and dropout in the TME quality of life substudy

Hormone therapy adjuvant to external beam radiotherapy for locally advanced prostate carcinoma

Maximum androgen blockade: a case study report

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