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Quality of Life After Prostate Cancer Treatment

Wake Forest University School of Medicine, Winston Salem, NC

To the Editor:I read with considerable interest the recent report by Wei et al¹ examining health-related quality of life (HRQOL) after definitive treatment for clinically localized prostate cancer. The authors are to be congratulated for integrating urinary irritative and hormonal domains into a reliable validated HRQOL instrument. I must admit, however, that I am puzzled by the magnitude of urinary HRQOL decrease seen in their patients treated with prostate brachytherapy (PB).

In the discussion section, the authors state that the HRQOL they observed after PB is "consistent with the limited available patient-reported data" from other series.¹ To support this claim, the authors provide results of the prostate cancer symptom subscale of the Functional Assessment of Cancer Therapy-Prostate and the International Prostate Symptom Score (IPSS) from our prospective series at Wake Forest.² It is important to point out that the scores they have taken from the Wake Forest experience were obtained from patients 1 to 3 months after PB, when acute urinary symptoms tend to be at their peak. The median time from treatment to questionnaire completion in the Michigan report is 21 months (range, four to 52 months). Two subsequent reports from Wake forest with longer follow-up have observed that the prostate cancer symptom and IPSS scores return to baseline within 12 months of PB.^3,4 In short, I am wondering why the Michigan patients nearly 2 years after treatment seem similar to the Wake Forest patients only 3 months after treatment?

Two possible explanations for this discrepancy are patient selection and treatment technique. Urinary morbidity after PB has been associated with higher IPSS scores and larger prostate volumes.⁵ From the beginning of our PB program, patients have been carefully selected for PB. Patients with significant urinary symptoms (IPSS greater than 12 to 15) or prostate volumes above 45 cc have been discouraged from treatment with PB. Do the authors have any information regarding pretreatment urinary function or prostate volume in men treated with PB?

Source loading technique is probably associated with morbidity. Wallner et al⁶ has reported that urinary morbidity is associated with high urethral doses. The American Brachytherapy Society has recommended a modified peripheral loading technique to reduce high doses in the center of the prostate gland and perhaps reduce urinary morbidity.⁷ Can the authors provide any information about the source loading technique? Did they use a Quimby method? Were there any constraints on maximum urethral doses? Finally, the authors report that the prescription dose was 160 Gy. Is this dose according to the TG-43 formalism? Is it higher than the 145 Gy recommended by the American Brachytherapy Society?

Although it is possible that either of these two explanations can account for the differences in urinary morbidity, without baseline information on HRQOL before treatment, it is impossible to know to what extent any particular treatment is responsible for observed HRQOL decline. As the Michigan group has shown, most evidence to date suggests that there are important differences in sexual, urinary, and bowel HRQOL according to treatment received. This underscores the importance of completing randomized trials in men with clinically localized prostate cancer. For the future, the Expanded Prostate Index Cancer instrument developed by the Michigan group will be an important component of prospective clinical trials examining PB to be completed by the American College of Surgeons Oncology Group and the Radiation Therapy Oncology Group.

REFERENCES

1. Wei JT, Dunn RL, Sandler HM, et al: Comprehensive comparison of health-related quality of life after contemporary therapies for localized prostate cancer. J Clin Oncol 20: 557-566, 2002[Abstract/Free Full Text]

2. Lee WR, McQuellon RP, Case LD, et al: Early quality of life assessment in men treated with permanent source interstitial brachytherapy for clinically localized prostate cancer. J Urol 162: 403-406, 1999[CrossRef][Medline]

3. Lee WR, McQuellon RP, Harris-Henderson K, et al: A preliminary analysis of health-related quality of life in the first year after permanent source interstitial brachytherapy (PIB) for clinically localized prostate cancer. Int J Radiat Oncol Biol Phys 46: 77-81, 2000[CrossRef][Medline]

4. Lee WR, Hall MC, McQuellon RP, et al: A prospective quality-of-life study in men with clinically localized prostate carcinoma treated with radical prostatectomy, external beam radiotherapy, or interstitial brachytherapy. Int J Radiat Oncol Biol Phys 51: 614-623, 2001[CrossRef][Medline]

5. Gelblum DY, Potters L, Ashley R, et al: Urinary morbidity following ultrasound-guided transperineal prostate seed implantation. Int J Radiat Oncol Biol Phys 45: 59-67, 1999[Medline]

6. Wallner K, Roy J, Harrison L: Dosimetry guidelines to minimize urethral and rectal morbidity following transperineal I-125 prostate brachytherapy. Int J Radiat Oncol Biol Phys 32: 465-471, 1995[CrossRef][Medline]

7. Nag S, Beyer D, Friedland J, et al: American Brachytherapy Society (ABS) recommendations for transperineal permanent brachytherapy of prostate cancer. Int J Radiat Oncol Biol Phys 44: 789-799, 1999[CrossRef][Medline]

Response

University of Michigan Medical Center, Ann Arbor, MI

In Reply:Dr. Lee’s letter is greatly appreciated and highlights important caveats to our manuscript. Principal among these is that selection criteria may vary between different institutions, thereby limiting the generalizability of any single institution’s experience with early-stage prostate cancer intervention, irrespective of whether the intervention is surgery, external radiation, or brachytherapy. Selection criteria for brachytherapy have undergone evolution since the period (1995 to 1999) when patients described in our cohort were treated, and brachytherapy techniques have been refined as well. It is possible that such improvements may lead to better health-related quality-of-life (HRQOL) outcomes.

Baseline function can reflect such evolving selection criteria, and therefore, prospective studies such as that reported by Lee et al^1,2 provide an important complement to the long-term data reported by cross-sectional studies.^3-5 Multi-institutional prospective studies and randomized clinical trials are the rational next step. Toward this goal, the Surgical Prostatectomy Interstitial Radiation Intervention Trial from the American College of Surgeons Oncology Group has been opened and will directly compare outcomes between patients randomized to prostatectomy versus brachytherapy. Trials to randomize subjects between brachytherapy alone versus brachytherapy combined with external radiation are under development by the Radiation Therapy Oncology Group. Perhaps the most relevant and durable observation from Wei et al⁵ is that such trials need to evaluate a spectrum of HRQOL domains that should include urinary irritative and hormonal concerns in addition to the previously established domains of urinary incontinence, sexual, and bowel HRQOL.^6-7

It should be noted that both the International Prostate Symptom Score (IPSS) and Functional Assessment of Cancer Therapy-Prostate (FACT-P) have limited sensitivity in this regard, and neither instrument was developed or validated for evaluating early-stage prostate cancer HRQOL. We reported IPSS and FACT-P scores only to provide context for our findings, as evidence suggesting that our observations were not outside of the range of possible expected results. Whether or not the posttherapy IPSS scores we observed (mean IPSS = 12.6 at 21 months) are substantially different from those observed by Lee et al² (IPSS = 13.7 at 6 months and 10.2 at 12 months) is debatable. We feel that more important than a comparison of FACT-P or IPSS scores between studies, however, is the recognition that IPSS and FACT-P have very limited utility for comparing HRQOL effects of different early-stage prostate cancer interventions.¹

At the time that our subjects received brachytherapy, the utility of baseline IPSS scores as an exclusion criterion for brachytherapy had not been well characterized, and so baseline IPSS score was not used as a selection criterion for therapy. Prostate size was considered, but more than 60 mL was not an absolute contraindication. Higher activity sources were used than we are currently using. In contrast to current planning margins, implants were planned with a wider margin posterior and below the prostate to ensure adequate coverage of the prostatic apex. These elements may have contributed to the observed HRQOL effects, but represented a high quality standard of brachytherapy in 1995 to 1999. Patients were planned with peripheral loading, and the 160-Gy dose was by the prior convention and equivalent to 145 Gy TG-43. Urethral doses were kept below 240 Gy.

REFERENCES

1. Lee WR, Hall MC, McQuellon RP, et al: A prospective quality of life study in men with clinically localized prostate carcinoma treated with radical prostatectomy, external beam radiotherapy, or interstitial brachytherapy. Int J Radiat Oncol Biol Phys 51: 614-623, 2001[CrossRef][Medline]

2. Lee WR, McQuellon RP, Harris-Henderson K, et al: A preliminary analysis of health-related quality of life in the first year after permanent source interstitial brachytherapy (PIB) for clinically localized prostate cancer. Int J Radiat Oncol Biol Phys 46: 77-81, 2000[CrossRef][Medline]

3. Talcott JA, Clark JC, Stark P, et al: Long-term treatment-related complications of brachytherapy for early prostate cancer: A survey of patients previously treated. J Urol 166: 494-499, 2001[CrossRef][Medline]

4. Davis JW, Kuban DA, Lynch DF, et al: Quality of life after treatment for localized prostate cancer: Differences based on treatment modality. J Urol 166: 947-952, 2001[CrossRef][Medline]

5. Wei JT, Dunn RL, Sandler HM, et al: A comprehensive comparison of health related quality of life following contemporary therapies for localized prostate cancer. J Clin Oncol 20: 557-566, 2002[Abstract/Free Full Text]

6. Litwin MS, Hays RD, Fink A, et al: Quality-of-life outcomes in men treated for localized prostate cancer [see comments]. JAMA 273: 129-135, 1995[Abstract]

7. Wei JT, Dunn RL, Litwin MS, et al: Development and validation of the expanded prostate cancer index composite (EPIC) for comprehensive assessment of health-related quality-of-life in men with prostate cancer. Urology 56: 899-905, 2000[CrossRef][Medline]

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