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Context:  In men who develop an elevated serum prostate-specific antigen level (PSA) after having undergone a radical prostatectomy, the natural history of progression to distant metastases and death due to prostate cancer is unknown.

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Patients:  A total of 1997 men undergoing radical prostatectomy, by a single surgeon, for clinically localized prostate cancer. None received neoadjuvant therapy, and none had received adjuvant hormonal therapy prior to documented distant metastases.

Main outcome measures:  After surgery, men were followed up with PSA assays and digital rectal examinations every 3 months for the first year, semiannually for the second year, and annually thereafter. A detectable serum PSA level of at least 0.2 ng/mL was evidence of biochemical recurrence. Distant metastases were diagnosed by radionuclide bone scan, chest radiograph, or other body imaging, which was performed at the time of biochemical recurrence and annually thereafter.

Conclusions:  Several clinical parameters help predict the outcomes of men with PSA elevation after radical prostatectomy. These data may be useful in the design of clinical trials, the identification of men for enrollment into experimental protocols, and counseling men regarding the timing of administration of adjuvant therapies.

Background:  Androgen deprivation is commonly prescribed for men with a rising prostate specific antigen level after radical prostatectomy, despite scant evidence regarding its efficacy and side effects. In the current study, the authors compared measures of health-related quality of life (HRQOL) in men who were treated with androgen deprivation after radical prostatectomy with those for men who underwent surgery but were not treated with androgen deprivation.

Methods:  Medicare Provider and Analysis and Review (MedPAR) files were used to identify men who had undergone radical prostatectomies between 1991-1992. Medicare Part B data then were used to select two samples: men who subsequently were androgen deprived and those who were not. In 1999, a mail survey was administered that addressed a range of disease-related and treatment-related issues, including HRQOL. Age-adjusted comparisons of responses to seven multiitem measures of HRQOL were performed.

Results:  The overall response rate was 82%. On all seven HRQOL measures (impact of cancer and treatment, concern regarding body image, mental health, general health, activity, worries about cancer and dying, and energy), there were statistically significant decrements associated with androgen deprivation.

Patients with locally advanced colon cancer (LACC) have a relatively poor prognosis despite radical resection and adjuvant chemotherapy. This study investigated the treatment efficacy and toxicity of neoadjuvant chemoradiotherapy in patients with LACC.

We retrospectively reviewed 36 patients with LACC preoperatively treated with chemotherapy and radiotherapy. Patients were administered chemoradiotherapy, which comprised radiotherapy and neoadjuvant chemotherapy involving a 5-fluorouracil, leucovorin, and oxaliplatin regimen every 2 weeks.

Our results demonstrated that neoadjuvant chemoradiotherapy is feasible and safe. A prominent pCR rate with an acceptable toxicity profile suggests that the multimodality therapy might be a treatment option for patients with LACC.

Worldwide, colorectal cancer is the third most commonly diagnosed cancer in men and the second most commonly diagnosed cancer in women [1]. In Taiwan, colorectal cancer is the most common cancer, with a rapid increase in its prevalence, and is the third leading cause of cancer-related death [2]. Complete tumor removal surgery with a margin negative resection (R0) is the only curative modality for localized colon cancer. However, treatment results for locally advanced colon cancer (LACC), which is clinically defined as a primary tumor that directly invades adjacent structures or by the presence of extensive nodal involvement that renders curative resection infeasible, remain disappointing despite recent developments in surgery with subsequent adjuvant chemotherapy [3, 4]. The 5-year survival rates for patients with stage IIC, IIIB, and IIIC LACC were reported to be 37.3%, 46.3 and 28%, respectively [5], which has prompted researchers to investigate new treatment approaches for LACC in order to resolve the problems of markedly low survival rates resulting from tumor invasion to adjacent organs or extensive lymph node metastasis.

The concurrent chemotherapy regimen was a biweekly schedule of FOLFOX. Each cycle of FOLFOX consisted of oxaliplatin (85 mg/m2) and folinic acid (400 mg/m2) infusion on day 1 followed by a 46-h infusion of 5-fluorouracil (5-FU, 2800 mg/m2) repeated every 2 weeks. All patients received concurrent chemotherapy and radiotherapy. After completion of radiotherapy, all patients received chemotherapy twice weekly until surgery. Patients underwent surgery about 4 weeks after completing preoperative chemotherapy.

Patients underwent elective surgery at >6 weeks after completion of radiotherapy. The pathologic tumor (T) and nodal (N) stages (ypT and ypN, respectively) of the tumor, histological grade, lymphovascular invasion, perineural invasion, tumor regression grade (TRG), and status of the circumferential, proximal, and distal resection margins were documented. The tumor response after CCRT was assessed according to the American Joint Committee on Cancer (AJCC) system as follows [18]: Grade 0, no residual cancer cells; Grade 1, single cell or small group of cancer cells (major regression); Grade 2, residual cancer with desmoplastic response (moderate regression); and Grade 3, minimal evidence of tumor response. A circumferential resection margin (CRM) of

Fifteen patients received an adjuvant chemotherapy regimen of FOLFOX. Adjuvant UFUR (tegafur and uracil) and capecitabine were administered in 11 and 5 patients, respectively; 3 patients did not receive postoperative chemotherapy. Two patients were transferred to the folinic acid, 5-FU, and irinotecan (FOLFIRI) regimen after laparotomy because of a poor response to the FOLFOX-based CCRT and the development of distant metastasis.

The pCR rate was the primary endpoint of the study. Secondary endpoints were multimodality therapy-associated toxicities, TGR, and R0 resection rate. Downstaging was determined according to the response between the clinical T or N stage before neoadjuvant CCRT and the postoperative pathological T or N stage.

Table 2 presents the acute adverse events during neoadjuvant CCRT. Overall, seven (19.4%) of the 36 patients experienced grade 3 or 4 adverse events during neoadjuvant CCRT. Leukopenia was defined according to the CTCAE, version 3.0, and leucopenia (83.2%) was the most common adverse event; however, most events (69.4%) were of grade 1 or 2 and were manageable in all patients. For non-hematologic toxicity, fatigue and nausea were the leading side effects caused by CCRT. Moreover, there were no grade 4 adverse events or neoadjuvant CCRT-related deaths.

Table 4 summarizes the pathologic evaluation of primary tumor after neoadjuvant CCRT compared with that of the initial clinical stage. Of the 23 patients with clinical T4 tumors, five (21.7%) achieved ypT0 after intensified neoadjuvant CCRT, and clinical T4 tumors in eight patients (34.8%) were downstaged to ypT0-2.

Surgical mortality was not observed within 30 days after surgery. Of the 34 patients, five (14.7%) experienced postoperative complications requiring medical or surgical interventions. One patient developed a wound abscess on a previous drainage site, which resulted in a postoperative enterocutaneous fistula at 3 weeks, and this healed following antibiotic treatment. Another patient developed an intra-abdominal infection because of anastomotic leakage at 1 month after right hemicolectomy and temporary ileostomy closure; this patient finally recovered after undergoing another ileostomy along with antibiotic treatment. Two patients required surgical interventions because of adhesion ileus; one patient underwent enterolysis 1 month after left hemicolectomy and the other required segmental resection of small bowel at 32 months after extended left hemicolectomy. One patient developed a postoperative chronic rectovaginal fistula at 7 months and died of tumor progression.

Overall and disease-free survival rates. a Overall survival rate and (b) disease-free survival rate in patients with locally advanced colon cancer receiving neoadjuvant chemoradiation and radical resection

According to our review of relevant literature, the present clinical study used the largest sample for investigating the role of combined neoadjuvant oxaliplatin-based chemoradiotherapy in the treatment of primary LACC [20]. Our data demonstrated that the intensified multimodality approach resulted in an excellent pCR rate of 26.4% with an acceptable toxicity profile. However, this multimodal therapy should be used cautiously in clinical practice because of the limited sample size and short follow-up period of the present study. Our results, nevertheless, suggest that intensified neoadjuvant CCRT should be considered as a treatment option for patients with LACC, particularly those with potentially threatened surgical resection margins.

Evidence has indicated that nodal involvement is a major predictor of oncologic outcomes in patients with colorectal cancer [21, 22]. In our study, 82.4% of the patients did not develop nodal diseases after neoadjuvant CCRT. Furthermore, in a surgical series, pathologically positive nodal involvement was observed in approximately 69% patients with LACC [23]. The high pN0 rate in our study may be attributable to the marked influence of the neoadjuvant CCRT. For locally advanced rectal cancer, the neoadjuvant CCRT has been associated with nodal downstaging and a decrease in the pathologic lymph node harvest [16, 24]. Our findings reveal a similar effect of the neoadjuvant CCRT on eradication of lymph node metastasis in LACC. However, OS and DFS rates did not differ significantly between the patients with and without nodal metastasis. 152ee80cbc

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