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At least 991 records · Page 55Linked to original sources
PubMed2001

Long-term urinary function after transperineal brachytherapy for patients with large prostate glands.

PURPOSE: To summarize longer-term postbrachytherapy morbidity in patients with prostate glands >50 cm3. METHODS AND MATERIALS: From 1997 to 1998, 33 patients with a transrectal ultrasound-based prostate volume >50 cm3 were treated at the University of Washington by 125I (144 Gy) or 103Pd (115 Gy) implantation for prostate carcinoma. These 33 patients comprised 7% of the total implant patient population. Twelve patients were treated with neoadjuvant androgen ablation before implantation. The (125)I source strength ranged from 0.34 to 0.5 mCi and the 103Pd source strength ranged from 1.1 to 1.4 mCi (pre-NIST-99). The total number of sources implanted was 94-223 (median 155). Despite the typical implant-related volume increase, the postimplant CT-defined prostate volumes were generally well-covered by the prescription isodose (median coverage 92%, range 80-100%). The preimplant urinary obstructive symptoms were quantified by the criteria of the American Urological Association. RESULTS: Of the 33 patients, 12 developed acute postimplant urinary retention, all presenting within 24 h of implantation. Patients who developed postimplant retention lasting >1 week were generally treated with intermittent self-catheterization. By 1 month, 85% of patients were catheter free. By 1 year, only 1 patient (4%) remained in urinary retention; the remainder of cases had resolved spontaneously. With follow-up of 1.7-2.6 years, the last American Urological Association scores were higher than the pretreatment scores in 15 patients and lower in 7 patients. No patient developed permanent urinary incontinence. Long-term changes in the American Urological Association scores were unrelated to whether the patient had been in urinary retention after implantation. Two patients developed rectal fistulas; they had preimplant transrectal ultrasound prostate volumes of 53 and 59 cm3, in the low range for this group of patients. No other patient had persistent rectal bleeding suggestive of clinically significant proctitis. The pretreatment serum prostate-specific antigen level was 3.3-15 ng/mL (median 7.2) and the last serum prostate-specific antigen level 0.1-1.6 ng/mL (median 0.2). CONCLUSION: Patients with larger prostate volumes appear to have moderate morbidity and a satisfactory technical outcome with brachytherapy. We do not believe the occurrence of two severe rectal complications was related to the prostate volume per se. Our experience and that of others calls into question the validity of using prostate volume as a criterion for patient suitability for prostate brachytherapy.

Brachytherapy↗
PubMed2002

Long-term outcome after elective irradiation of the pelvic lymphatics and local dose escalation using high-dose-rate brachytherapy for locally advanced prostate cancer.

PURPOSE: To report the 8-year outcome of local dose escalation using high-dose-rate conformal brachytherapy combined with elective irradiation of the pelvic lymphatics for localized prostate cancer. METHODS AND MATERIALS: One hundred forty-four consecutively treated men (1986-1992) were recorded prospectively. Twenty-nine (20.14%) patients had T1b-2a tumors, and 115 (79.86%) patients had T2b-3 tumors according to, respectively, American Joint Committee on Cancer/Union Internationale Contre le Cancer 1992. All patients had a negative nodal status, proven by CT or MRI. The mean initial PSA value was 25.61 ng/mL (Initial value for 41.66% of patients was <10 ng/mL, for 21.52% was 10-20 ng/mL, and for 32.63% was >20 ng/mL). The total dose applied by external beam radiotherapy was 50 Gy in the pelvis and 40 Gy in the prostate. The high-dose-rate brachytherapy was delivered in two fractions, which were incorporated into the external beam treatment (after 20-Gy and 40-Gy external beam radiotherapy dose). The dose per fraction was 15 Gy for the PTV1 (peripheral prostate zone) and 9 Gy for the PTV2 (entire prostatic gland). Any patient free of clinical or biochemical evidence of disease was termed bNED. Actuarial rates of outcome were calculated by Kaplan-Meier and compared using the log-rank. Cox regression models were used to establish prognostic factors of the various measures of outcome. RESULTS: The median follow-up was 8 years (range 60-171 months). The overall survival rate was 71.5%, and the disease-free survival rate was 82.6%. The bNED survival rate was 72.9%. Freedom from local recurrence for T3 stage was 91.3%, whereas for G3 lesions it was 88.23%. Freedom from distant recurrence for T3 stage was 82.6% and for G3 lesions 70.59%. Univariate survival analyses revealed that low stage (T1-2), low grade (G1-2), no hormonal therapy, initial PSA value less than 40 ng/mL, and PSA normalization <1.0 ng/mL after irradiation were associated with long survival. In multivariate analyses, initial PSA value, PSA kinetics after radiation therapy, and no adjuvant hormonal treatment were independent prognostic factors. Grade 3 late radiation toxicity (according to RTOG/EORTC scoring scheme) was 2.3% for the genitourinary system in terms of cystitis and 4.10% for the gastrointestinal system in terms of proctitis. Grades 4 and 5 genitourinary/gastrointestinal morbidity was not observed. A history of transurethral resection of the prostate with a median interval of less than 6 months from radiotherapy was associated with a high risk of genitourinary toxicity. CONCLUSION: The 8-year results confirm the feasibility and effectiveness of combined elective irradiation of the pelvic lymphatics and local dose escalation using high-dose-rate brachytherapy for cure of localized and especially high-risk prostate cancer.

Analysis of Variance↗
PubMed2002

Use of intraoperative electron beam radiotherapy in the management of retroperitoneal soft tissue sarcomas.

PURPOSE: To evaluate the disease control, survival results, and tolerance of intraoperative electron beam radiotherapy (IOERT) as a component of treatment for retroperitoneal soft tissue sarcomas. METHODS AND MATERIALS: Between March 1981 and September 1995, 87 patients with primary (n = 43) or recurrent (n = 44) retroperitoneal or intrapelvic sarcomas received IOERT as a component of treatment at the Mayo Clinic. The tumors were high grade in 54 patients (62%) and low grade in 33 (38%). The median tumor size was 10 cm (range 2-36). All patients underwent maximal surgical resection with IOERT; in 72 patients, only microscopic or no residual tumor remained. The IOERT doses ranged from 8.75 to 30 Gy (median 15). All primary tumors received external beam irradiation (EBRT) with a median dose of 48.6 Gy. Thirty-four of the 44 recurrent tumors received EBRT to a median dose of 45 Gy. All patients were followed prospectively for outcome and toxicity evaluation. RESULTS: The median follow-up, based on 46 patients (53%) currently alive, was 3.5 years. The overall estimated 5-year survival was 47%. For patients with tumors > or = 10 cm, the 5-year overall survival was significantly poorer (28%) than for those with smaller lesions (60%) (p = 0.01). Neither primary vs. recurrent status nor tumor grade had a significant impact on survival. Patients with gross residual tumor had a marginally significantly poorer survival compared with patients with microscopic or no residual tumor, with a 5-year survival rate of 37% and 52%, respectively (p = 0.08). A total of 49 patients (56%) experienced failure, including 20 local recurrences (23%). The median time to failure was 2.3 years. Four recurrences were within the IOERT field, 3 within the IOERT and EBRT field, and 13 within the EBRT field alone. The 3- and 5-year estimated local control rate was 77% and 59%, respectively. Local control was marginally significantly affected by the amount of residual tumor, with a 5-year local control rate of 41% for those with gross residual tumor, 60% for those with microscopic residual tumor, and 100% for those with no residual tumor (p = 0.09). Gastrointestinal complications were recorded in 12 incidences (Grade 3 or higher toxicity). These complications were believed to be secondary to surgery and/or EBRT in 10 of the 12 cases. Seven patients had fistula formation, and 3 experienced severe proctitis. Grade 3 peripheral neurologic toxicities occurred in 9 patients (10%), but none had pain as a component of their neuropathy. CONCLUSION: Retroperitoneal soft tissue sarcomas can be treated with an aggressive combined approach of EBRT, surgery, and IOERT, with acceptable toxicity. Local control in primary disease appears to be improved in this retrospective series with this approach. Distant disease control and options for recurrent disease needs further definition.

Adolescent↗
PubMed2002

Long-term control of T2-T3 rectal adenocarcinoma with radiotherapy alone.

PURPOSE: To analyze the long-term result of patients presenting with T2-T3 rectal adenocarcinoma treated with curative intent by radiotherapy (RT) alone, using a combination of contact RT, external beam RT, and brachytherapy with an iridium implant. Patients were considered unsuitable for surgery because of the presence of severe comorbidity or because they did not consent to surgery and the possibility of a permanent stoma. METHODS AND MATERIALS: Between 1986 and 1998, 63 patients (56 staged with endorectal ultrasonography) were entered into a pilot study. Patients had to have T2-T3, N0-N1, M0 adenocarcinoma of the middle or lower rectum involving less than two-thirds of the circumference. RT began with contact X-rays (80 Gy in 3 fractions for 21 days), followed by external beam RT (39 Gy in 13 fractions for 17 days) with a concomitant boost (4 Gy in 4 fractions). After a 4-6-week interval, an iridium implant delivered a completion dose of 20 Gy to the tumor. No chemotherapy was given. RESULTS: The median age of the patients was 72 years. Of the 63 patients, 41 had T2 and 22 had T3 tumors. The mean distance of the tumor from the anal verge was 3.6 cm. All patients completed treatment according to the protocol, except for 7 for whom brachytherapy was not performed. With a median follow-up time of 54 months, the primary local tumor control rate was 63%; after salvage surgery, the ultimate pelvic control was 73% (46 of 63). The 5-year overall survival rate was 64.4%, and for 42 patients aged <80 years, it was 78% with 10 patients alive and well at > or =10 years. No severe Grade 3-4 toxicity was seen. Acute proctitis was seen in most patients but did not require treatment interruption. Late rectal bleeding occurred in 24 patients. Only 1 required blood transfusion. Good anorectal function was maintained in 92% of living patients. The T stage was a strong prognostic factor, with a 5-year overall survival rate of 84% and 53% for T2 and T3 lesions, respectively, in patients <80 years old. CONCLUSION: This is the first report of long-term local control and survival for ultrasound-staged T2-T3 rectal adenocarcinoma treated by RT alone, showing that high-dose irradiation to a small volume can provide a high therapeutic ratio for such tumors.

Adenocarcinoma↗
PubMed2002

A pilot study of topical intrarectal application of amifostine for prevention of late radiation rectal injury.

PURPOSE: Clinical symptomatic late injury to the rectal wall occurs in about one-third of patients with prostate cancer treated with external beam irradiation. Reducing the physical dose to the anterior rectal wall without a similar reduction in the posterior peripheral zone is difficult because of the proximity of the prostate to the anterior rectal wall. On the basis of our previous observations in an animal model that intrarectal application of amifostine resulted in very high concentrations of amifostine and its active metabolite WR-1065 in the rectal wall, a Phase I dose-escalation clinical trial was undertaken. METHODS AND MATERIALS: Twenty-nine patients with localized prostate cancer were accrued. Eligibility criteria included histologically confirmed adenocarcinoma, Karnofsky performance status >or=70, and no pelvic lymphadenopathy or distant metastases. The total dose to the prostate was 70.2 Gy in 20 patients and 73.8 Gy in 9 patients. Therapy was delivered using a 4-field technique with three-dimensional conformal planning. Amifostine was administered intrarectally as an aqueous solution 30 min before irradiation on the first 15 days of therapy. Amifostine was escalated in cohorts from 500 to 2500 mg. Proctoscopy was performed before therapy and at 9 months after completion. Most patients underwent repeat proctoscopy at 18 months. On Days 1 and 10 of radiotherapy, serum samples were collected for pharmacokinetic studies. The clinical symptoms (Radiation Therapy Oncology Group scale) and a proctoscopy score were assessed during follow-up. RESULTS: All patients completed therapy with no amifostine-related toxicity at any dose level. The application was feasible and well tolerated. No substantial systemic absorption occurred. With a median follow-up of 26 months, 9 patients (33%) developed rectal bleeding (8 Grade 1, 1 Grade 2). At 9 months, 16 and 3 patients developed Grade 1 and Grade 2 telangiectasia, respectively. This was mostly confined to the anterior rectal wall. No visible mucosal edema, ulcerations, or strictures were noted. No significant differences were found between the proctoscopy findings at 9 and 18 months. Four patients (14%) developed symptoms suggestive of radiation damage that, on sigmoidoscopy, proved to be secondary to unrelated processes. These included preexisting nonspecific proctitis (n = 1), diverticular disease of the sigmoid colon (n = 1), rectal polyp (n = 1), and ulcerative colitis (n = 1). Symptoms developed significantly more often in patients receiving 500-1000 mg than in patients receiving 1500-2500 mg amifostine (7 [50%] of 14 vs. 2 [15%] of 13, p = 0.0325, one-sided chi-square test). CONCLUSION: Intrarectal application of amifostine is feasible and well tolerated. Systemic absorption of amifostine and its metabolites is negligible, and close monitoring of patients is not required with rectal administration. Proctoscopy is superior to symptom score as a method of assessing radiation damage of the rectal wall. The preliminary efficacy data are encouraging, and further clinical studies are warranted.

Adenocarcinoma↗
PubMed2002

Interstitial brachytherapy for salvage treatment of vaginal recurrences in previously unirradiated endometrial cancer patients.

PURPOSE: To evaluate whether interstitial brachytherapy can effectively salvage vaginal recurrence from endometrial carcinoma. METHODS AND MATERIALS: Between September 1989 and September 2000, 13 previously unirradiated patients (mean age 70 years) with isolated vaginal recurrences from endometrial adenocarcinoma were treated with interstitial low-dose-rate brachytherapy with or without additional external beam radiotherapy. Brachytherapy was delivered using a modified perineal Syed template loaded with (192)Ir. The central cylinder was loaded with high-activity (192)Ir (n = 12) or (137)Cs (n = 1). RESULTS: The patients had initially presented with FIGO Stage I (n = 11) or III (n = 2) cancer. Vaginal recurrences were diagnosed at a mean interval of 27.5 months after hysterectomy (range 2-83). The patients were followed for a median of 60 months (range 15-105). Ten patients had recurrence at the vaginal apex and three had recurrence in the lower two-thirds of the vagina. The median time to recurrence was 22 months. The tumor size ranged from 1.5 to 6 cm (mean 2.2, median 2.5). Eleven of 13 patients received 45-50-Gy pelvic external beam radiotherapy, followed by a mean interstitial brachytherapy boost of 28.3 Gy (range 18-35). The 2 other patients received brachytherapy only of 40 Gy and 50 Gy, respectively. All tumors were locally controlled. Three (23%) of 13 patients had a relapse at distant sites (two in the paraaortic region and one in the liver). The overall 8-year actuarial disease-specific survival rate was 77%. Major (Grade 3 and 4) long-term morbidity occurred in 2 patients (15%) and included Grade 3 vaginal ulceration in 1 patient, and Grade 4 colovesical fistula requiring surgical intervention in 1 patient. Additional long-term morbidity included Grade 2 proctitis in 1 patient. CONCLUSION: Interstitial brachytherapy with or without supplementary external beam radiotherapy can effectively salvage vaginal recurrence from endometrial cancer with very favorable local control and overall survival and acceptable morbidity.

Adenocarcinoma↗
PubMed1997

Late GI and GU complications in the treatment of prostate cancer.

PURPOSE: To assess the factors that predict late GI and GU morbidity in radiation treatment of the prostate. METHODS AND MATERIALS: Seven hundred twelve consecutive prostate cancer patients treated at this institution between 1986 and 1994 (inclusive) with conformal or conventional techniques were included in the analysis. Patients had at least 3 months follow-up and received at least 65 Gy. Late GI Grade 3 morbidity was rectal bleeding (requiring three or more procedures) or proctitis. Late Grade 3 GU morbidity was cystitis or stricture. Multivariate analysis (MVA) was used to assess factors related to the complication-free survival. The factors assessed were age, occurrence of side effects > or = Grade 2 during treatment, irradiated volume parameters (use of pelvic fields, treatment of seminal vesicles to full dose or 57 Gy, and use of additional rectal shielding), dose, comorbidities, and other treatments (hormonal manipulation, TURP). RESULTS: Acute GI and GU side effects (Grade 2 or higher) were noted in 246 and 201 patients, respectively; 67 of these patients exhibited both. GI side effects were not correlated with GU side effects acutely. Late and acute morbidities were correlated (both GI and GU). Fifteen of the 712 patients expressed Grade 3 or 4 GI injuries 3 to 32 months after the end of treatment, with a mean of 14.3 months. One hundred fifteen patients expressed Grade 2 or higher GI morbidity (mean: 13.7 months). The 43 Grade 2 or higher GU morbidities occurred significantly later (mean: 22.7 months). Central axis dose was the only independent variable significantly related to the incidence of late GI morbidity on MVA. No treatment volume parameters were significant for Grade 3. The following parameters were significantly related (by MVA) to Grade 2 GI morbidity: central axis dose, use of the increased rectal shielding, androgen deprivation therapy starting before RT. Acute and late GI morbidities were highly correlated. History of diabetes, treatment of pelvic nodes, and age less than 60 years were significantly related to acute GI side effects. The parameters significantly related to late Grade 2 or higher GU morbidity were central axis dose, androgen deprivation therapy (Zoladex or Lupron) prior to radiation therapy (RT), history of obstructive symptoms, and acute GU side effects. There were too few late Grade 3 GU morbidities to perform multivariate analysis. Acute GU side effects were highly correlated with late GU injury. The following were correlated with acute GU side effects: history of diabetes (+), treatment with conformal fields (-), TURP before RT (-), presentation with urinary obstructive symptoms. CONCLUSION: Both late GI and GU morbidity demonstrate a dose dependence, but only the volume dependence observed is a reduction in late Grade 2-4 GI morbidity by increasing the rectal shielding in the lateral fields for the final 10 Gy. Moreover, both late GI and GU morbidity was increased in patients treated with hormone manipulation prior to RT. GI and GU injuries were correlated with their corresponding acute side effects. GI and GU complications must not be combined for analysis to determine the factors related to their occurrence.

Antineoplastic Agents, Hormonal↗
PubMed1997

Biochemical disease-free survival following 125I prostate implantation.

PURPOSE: To assess the 5-year clinical and biochemical results of ultrasound-guided permanent 125I brachytherapy in early adenocarcinoma of the prostate. Biochemical disease-free survival (BDFS) is reported, using PSA follow-up and is compared to the surgical and radiation therapy literature. METHODS AND MATERIALS: From December 1988 through December 1993, ultrasound-guided brachytherapy was preplanned with 125I and delivered 160 Gy as the sole treatment in 499 patients. All were clinically staged as T1 or T2 node-negative adenocarcinoma of the prostate. Within the first year, 10 patients were lost to follow-up and have been excluded from further study. The remaining 489 patients form the basis of this report. Clinical status and prostate specific antigen (PSA) values were systematically recorded before and after treatment. RESULTS: With a median follow-up of 35 months (3-70), the actuarial clinical local control is 83%. Both stage and grade are shown to predict for this endpoint. Actuarial biochemical disease-free survival (BDFS) is also correlated with stage, grade, and PSA at presentation. Biochemical disease-free survival at 5 years is 94% for T1, 70% for unilateral T2, and 34% for T2c tumors. Grade is also predictive, ranging from 85% in low-grade tumors to 30% in high-grade tumors. In a multivariate analysis, the pretreatment PSA is most highly correlated (p < 0.0001) with BDFS, local control, and clinical disease-free survival. Patients with a normal pretreatment PSA enjoyed 93% BDFS, while those presenting with PSA > 10 had a BDFS of 40%. Complications have been few, with severe urinary urgency or dysuria in 4% and both incontinence and proctitis seen in 1%. CONCLUSIONS: While biochemical disease-free survival reports in the literature are immature and have short follow-up, our data compares favorably with studies following radical prostatectomy or radiation therapy. Further follow-up of this cohort is required. The complication rate is low and patient acceptance excellent. Permanent implantation of 125I as the sole treatment for early prostate adenocarcinoma is a viable alternative for patients with early-stage and low- to moderate-grade cancers. The PSA provides significant prognostic information and aids in case selection. Better management options are needed for high grade and bilateral tumors.

Adenocarcinoma↗
PubMed1997

Cost benefit of emerging technology in localized carcinoma of the prostate.

PURPOSE: In a health care environment strongly concerned with cost containment, cost-benefit studies of new technology must include analyses of loco-regional tumor control, morbidity, impact on quality of life, and financial considerations. METHODS AND MATERIALS: This nonrandomized study analyzes 124 patients treated with three-dimensional conformal radiation therapy (3D CRT) and 153 with standard irradiation (SRT) between January 1992 and December 1995, for histologically proven adenocarcinoma of prostate, clinical Stage T1 or T2. Mean follow-up is 1.4 years. Three-dimensional CRT consisted of six or seven coplanar oblique and lateral and, in some patients, AP fields designed to treat the prostate with a 1 to 1.7 cm margin. SRT consisted of 120 degrees bilateral arc rotation. Total doses to prostate were 67 to 70 Gy when pelvic lymph nodes were irradiated or 68.4 to 73.8 Gy when prostatic volume only was treated; dose per fraction was 1.8 Gy. Patients were interviewed weekly for severity of 12 acute intestinal and urinary pelvic irradiation side effects (0 to 4+ grading). Time and effort for 3D RTP and daily treatment with 3D CRT and SRT were recorded. Dose-volume histograms (DVHs) were calculated for gross tumor volume, planning target volume, bladder, and rectum. Actual reimbursement to the hospital and university was determined for 41 3D CRT, 43 SRT, and 40 radical prostatectomy patients treated during the same period. RESULTS: Average treatment planning times (in minutes) were: 101 for 3D conformal therapy simulation, 66 for contouring of target volume and sensitive structures, 55 for virtual simulation, 39 for plan preparation and documentation, 65 for physical simulation, and 20 for approval of treatment plan. Daily mean treatment times were 19 min for 3D CRT with Cerrobend blocking, 16 with multileaf collimation, and 10 with bilateral arc rotation. Dosimetric analysis (DVHs) showed a reduction of 50% in volume of bladder or rectum receiving doses higher than 65 Gy. Acute side effects included dysuria, moderate difficulty in urinating, and nocturia in 25-39% of both SRT and CRT patients; loose stools or diarrhea in 5-12% of 3D CRT and 16-22% of SRT patients; moderate proctitis in 3% of 3D CRT and 12% of SRT patients (p = 0.01). Chemical disease-free survival (prostate-specific antigen < or =2 ng/ml) at 3 years was 90% with 3D CRT and 80% with SRT (p = 0.01). Average initial treatment reimbursements were $13,823 (3D CRT), $10,864 (SRT), and $12,250 (radical prostatectomy). Average total treatment reimbursement and projected cost of management of initial therapy failures per patients were $15,173, $16,264, and $16,405, respectively. CONCLUSIONS: Three-dimensional CRT irradiated less bladder and rectum volume than SRT; CRT initial reimbursement was 28% higher than SRT and 12% higher than radical prostatectomy. Because of projected better local tumor control, average total cost of treating a patient with 3D CRT or radical prostatectomy is equivalent to cost of SRT. Treatment morbidity was lower with 3D CRT. Our findings reflect an overall benefit with 3D CRT as a new promising technology in treatment of localized prostate cancer. Dose-escalation studies may enhance its efficacy and cost benefit.

Adenocarcinoma↗
PubMed1998

Phase I dose escalating trial of hyperfractionated pre-operative chemoradiation for locally advanced rectal cancer.

PURPOSE: To determine the acute toxicity, post-operative complications, pathologic response and extent of downstaging to high dose pre-operative radiation using a hyperfractionated radiation boost and concurrent chemotherapy in a prospective Phase I trial. MATERIALS & METHODS: To be eligible for this study, patients had to have adenocarcinoma of the rectum less than 12 cm from the anal verge with either Stage T4 or T3 but greater than 4 cm or greater than 40% of the bowel circumference. All patients received 45 Gy pelvic radiation (1.8 Gy per fraction). Subsequent radiation was given to the region of the gross tumor with a 2 cm margin. This "boost" treatment was given at 1.2 Gy twice daily to a total dose of 54.6 Gy for Level I, 57 Gy for Level II, and 61.8 Gy for Level III. 5-FU was given at 1g/m2 over 24 hours for a four day infusion during the first and sixth weeks of radiation, with the second course concurrent with the hyperfractionated radiation. Surgical resection was carried out 4-6 weeks following completion of chemoradiation (in curative cases) and additional adjuvant chemotherapy consisting of 5-FU and Leucovorin was given for an additional 4 monthly cycles Days 1 through 5 beginning four weeks post surgery. RESULTS: Twenty-seven patients, age 40-82 (median 61), completed the initial course of chemoradiation and are included in the analysis of toxicity. The median follow-up is 27 months (range 8-68). Eleven patients were treated to a dose of 54.6 Gy, nine patients to 57 Gy, and seven patients to 61.8 Gy. Twenty-one patients had T3 tumors, and six patients T4 tumors. Grade III acute toxicity from chemoradiation included proctitis (5 patients), dermatitis (9), diarrhea (five), leukopenia (1), cardiac (1). Grade IV toxicities included one patient with diarrhea (on dose Level I) and one patient (on dose Level III) with cardiac toxicity (unrelated to radiation). Surgical resection consisted of abdominal perineal resection in 16 and low anterior resection in 7. Four patients did not undergo a curative resection; three initially presented with metastases and one developed metastasis during the pre-operative regimen. Post-operative complications included pelvic or perineal abscess in two (on dose Levels I & II), and delayed wound healing in two (one of whom, on dose Level III, developed perineal wound dehiscence requiring surgical reconstruction). Of the 23 patients who had a curative resection, four manifested pathologic complete responses (17.4%). Thirteen of 23 patients (57%) had evidence of pathologic downstaging and only 1/23 patients (on dose Level I) had a positive resection margin. Of these 23 patients (with a minimum follow-up of 8 months), the patient with positive margins was the only one who developed a local failure (Fisher's Exact p=.04). The 3-year actuarial OS, DFS and LC rates are 82%, 72% and 96%, respectively. Twelve of 13 patients (92% at 3 years) > or = 61 years vs. 5/10 patients (45% at 3 years) < 61 years remained disease-free (log-rank p=0.017). CONCLUSION: This regimen of high dose pre-operative chemoradiation employing a hyperfractionated radiation boost is feasible and tolerable and results in significant downstaging in locally advanced rectal cancer. The vast majority of patients (96%) achieved negative margins, which appears to be a prerequisite for local control (p= 0.04). Older age (> or =61 years) was a significant predictor for improved DFS. This regimen (at dose Level III, 61.8 Gy) is currently being tested in a Phase II setting.

Adenocarcinoma↗
PubMed1998

Conformal proton therapy for prostate carcinoma.

BACKGROUND: The role and optimum dose of radiation to eradicate prostate cancer continues to be evaluated. Protons offer an opportunity to increase the radiation dose to the prostate while minimizing treatment toxicity. METHODS: Six hundred forty-three patients with localized prostate cancer were treated with protons, with or without photons. Treatments were planned with a 3D planning system; patients received 74-75 CGE (Cobalt Gray Equivalent) at 1.8-2.0 CGE per fraction. Patients were evaluated for response to therapy and treatment-related toxicity. RESULTS: The overall clinical disease-free survival rate was 89% at 5 years. When post-treatment prostate-specific antigen (PSA) was used as an endpoint for disease control, the 4.5-year disease-free survival rate was 100% for patients with an initial PSA of < 4.0 ng/ml, and 89%, 72%, and 53% for patients with initial PSA levels of 4.1-10.0, 10.1-20.0, and > 20.0, respectively. Patients in whom the post-treatment PSA nadir was below 0.5 ng/ml did significantly better than those whose nadir values were between 0.51-1.0 or > 1.0 ng/ml: the corresponding 5-year disease-free survival rates were 91%, 79%, and 40%, respectively. Minimal radiation proctitis was seen in 21% of patients; toxicity of greater severity was seen in less than 1%. CONCLUSION: Proton therapy to 74-75 CGE produced minimal treatment-related toxicity and excellent PSA normalization and disease-free survival in patients with low initial PSA levels. A prospective randomized dose-escalation trial is now underway to help define the optimum dose of radiation for patients with early stage prostate cancer.

Analysis of Variance↗
PubMed1998

Irradiation in carcinoma of the vulva: factors affecting outcome.

PURPOSE: This report reviews the increasing role of radiation therapy in the management of patients with histologically confirmed vulvar carcinoma, based on a retrospective analysis of 68 patients with primary disease (2 in situ and 66 invasive) and 18 patients with recurrent tumor treated with irradiation alone or combined with surgery. METHODS AND MATERIALS: Of the patients with primary tumors, 14 were treated with wide local excision plus irradiation, 19 received irradiation alone after biopsy, 24 were treated with radical vulvectomy followed by irradiation to the operative fields and inguinal-femoral/pelvic lymph nodes, and 11 received postoperative irradiation after partial or simple vulvectomy. The 18 patients with recurrent tumors were treated with irradiation alone. Indications and techniques of irradiation are discussed in detail. RESULTS: In patients treated with biopsy/local excision and irradiation, local tumor control was 92% to 100% in Stages T1-3N0, 40% in similar stages with N1-3, and 27% in recurrent tumors. In patients treated with partial/radical vulvectomy and irradiation, primary tumor control was 90% in patients with T1-3 tumors and any nodal stage, 33% in patients with any T stage and N3 lymph nodes, and 66% with recurrent tumors. The actuarial 5-year disease-free survival rates were 87% for T1N0, 62% for T2-3N0, 30% for T1-3N1 disease, and 11 % for patients with recurrent tumors; there were no long-term survivors with T4 or N2-3 tumors. Four of 18 patients (22%) treated for postvulvectomy recurrent disease remain disease-free after local tumor excision and irradiation. In patients with T1-2 tumors treated with biopsy/wide tumor excision and irradiation with doses under 50 Gy, local tumor control was 75% (3 of 4), in contrast to 100% (13 of 13) with 50.1 to 65 Gy. In patients with T3-4 tumors treated with local wide excision and irradiation, tumor control was 0% with doses below 50 Gy (3 patients) and 63% (7 of 11) with 50.1 to 65 Gy. In patients with T1-2 tumors treated with partial/radical vulvectomy and irradiation, local tumor control was 83% (14 of 17), regardless of dose level, and in T3-4 tumors, it was 62% (5 of 8) with 50 to 60 Gy and 80% (8 of 10) with doses higher than 60 Gy. The differences are not statistically significant. There was no significant dose response for tumor control in the inguinal-femoral lymph nodes; doses of 50 Gy were adequate for elective treatment of nonpalpable lymph nodes, and 60 to 70 Gy controlled tumor growth in 75% to 80% of patients with N2-3 nodes when administered postoperatively after partial or radical lymph node dissection. Significant treatment morbidity included one rectovaginal fistula, one case of proctitis, one rectal stricture, four bone/skin necroses, four vaginal necroses, and one groin abscess. CONCLUSIONS: Irradiation is playing a greater role in the management of patients with carcinoma of the vulva; combined with wide local tumor excision or used alone in T1-2 tumors, it is an alternative treatment to radical vulvectomy, with significantly less morbidity. Postradical vulvectomy irradiation in locally advanced tumors improves tumor control at the primary site and the regional lymphatics in comparison with reports of surgery alone.

Adenocarcinoma↗
PubMed2004

[Acute cytomegalovirus (CMV) recto-colitis mimicking rectal carcinoma without apparent cause of immunodeficiency].

Cytomegalovirus (CMV) infection of the gastrointestinal tract occurs mainly in immunosuppressed patients. We report here the case of a 76-Year-old woman, without obvious cause of immunosuppression, who developed severe proctitis. The clinical course was favourable with ganciclovir therapy. In the absence of controlled data in the field of CMV intestinal infections in immunocompetents, we discuss the potential benefit of an antiviral therapy in those patients who do not recover rapidly and spontaneously.

Acute Disease↗
PubMedDate not supplied

Incidence of inflammatory bowel disease in the French West Indies (1997-1999).

OBJECTIVES: To investigate the incidence of inflammatory bowel disease in the French West Indies. METHODS: From January 1st 1997 to December 31st 1999 all patients observed with clinical symptoms suggestive of inflammatory bowel disease attending gastroenterologists practicing in Guadeloupe and Martinique were included. Patients were interviewed with a standard questionnaire to record data used by an expert to establish the final diagnosis of definite, probable or possible Crohn's disease, ulcerative colitis, unclassifiable chronic colitis or acute colitis, according to the EPIMAD registry. RESULTS: Sixty-six cases of ulcerative colitis (47.48%) including 12 cases of ulcerative proctitis (18.18% of the ulcerative colitis cohort), 55 of Crohn's disease (39.57%), 11 of unclassifiable chronic colitis (7.91%), and 7 of acute colitis (5.04%) were recorded. The crude annual incidence (per 100,000 inhabitants) based on definite and probable cases only was 2.44 for ulcerative colitis and 1.94 for Crohn's disease. The female/male ratio and median age at time of diagnosis were 1.61 and 29 years for Crohn's disease and 1.46 and 34 years for ulcerative colitis respectively. The median time from symptom onset to diagnosis was 2 months for both diseases. CONCLUSIONS: The observed incidence of inflammatory bowel disease In the French West-Indies is lower than in metropolitan France. These data will serve as a basis to assess disease evolution.

Adolescent↗
PubMed2000

Medical treatment: does it influence the natural course of inflammatory bowel disease?

It is difficult to predict the clinical course of inflammatory bowel disease (IBD). Moderately sick Crohn's disease (CD) patients and patients with distal ulcerative colitis (UC) may get better even without medical or surgical treatment. Once better, they may continue in remission even without treatment. If they are not treated, there are several factors that predict whether they will maintain remission. Most patients will probably alternate between remission and relapse, with 10% having a relapse-free course after 10 years, and only 1% having a continuously active course. Frequent relapses initially are associated with active disease later on, but the disease activity course is independent of the response to the initial medical treatment. There is a cumulative frequency of operation of 50-80% and of reoperation of 33% in CD, which suggests that CD has a more serious course than UC. In UC, the overall probability of surgery is 33% for pancolitis and 10% for proctitis within 5 years of diagnosis, and the majority of patients are operated on within the first few years. Maintenance treatment with sulphasalazine (SASP) and 5-aminosalicylic acid (5-ASA) in UC has reduced relapse rates to about half over a 1-year follow-up period. The use of 5-ASA for maintenance of CD has been shown to result in only a modest therapeutic gain, while azathioprine and 6-mercaptopurine (6-MP) improve the relapse frequency for at least 3 years whilst on treatment. Changes in disease distribution in UC are part of the natural course of the disease, which should have implications for medical treatment strategies, and affects the risk of colectomy and colonic cancer. Certain enviromental factors are thought to determine disease activity and disease outcome in UC and CD. Patient compliance with prescribed medication and clinical check-ups must be considered another non-specific variable affecting the clinical outcome. IBD frequently requires potent medication with side effects that limit patients' acceptance. Such patients often resort to medicinal herbs, acupuncture, and homeopathy, which may alter the expected course.

Journal Article↗
PubMed1998

Surgery or radiation: is there really a choice for early prostate cancer.

One of the most difficult tasks for the practicing urologist is to counsel the patient in a decision for the optimal treatment for his localized prostate cancer. After providing the patient with contemporary and unbiased information and data, it is important to find the preferred treatment based on his age, the medical realities and, last but not least, the patient's personal preference. Radical prostatectomy, radiotherapy and observation are standard treatment options. TRUS-guided brachytherapy and cryosurgery are considered investigational treatment options since follow-up is inadequate to provide sufficiently precise outcome estimates. The literature does not provide clear-cut evidence for the superiority of any one treatment. The patient most likely to benefit from radical prostatectomy would have a relatively long life expectancy, no significant surgical risk factors and a preference to undergo surgery. The major advantage of radical prostatectomy is its potential for total removal of the cancer and cure in properly selected patients. Potential harm includes urinary incontinence and impotence. The patient most likely to benefit from radiation therapy would have a relatively long life expectancy, no significant risk factors for radiation toxicity and a preference for radiotherapy. The advantages of radiotherapy are that it has a potential for cure and it is well tolerated in the majority of men when the modern techniques are used. Potential harm includes radiation cystitis, proctitis and impotence, persisting severe complications are only seen in 1% of patients. The patient most likely to benefit from surveillance are those with a shorter life expectancy and/or a low grade tumour. Benefits are lack of treatment related morbidity with only marginal compromise of disease-specific survival at 5-10 years follow-up.

Humans↗
PubMed2003

IgE and non-IgE food allergy.

BACKGROUND: Food allergy (FA) is characterized by an abnormal immunologic reactivity to food proteins. The gastro-intestinal tract serves not only a nutritive function but also is a major immunologic organ. Although previously thought to be triggered primarily by an IgE-mediated mechanism of injury, considerable evidence now suggests that non-IgE mechanisms may also be involved in the pathogenesis of FA. OBJECTIVE: To review the immunologic disturbances that occur in FA and to correlate these with the clinical manifestations expressed in affected target organs based upon a classification of IgE and non-IgE mechanisms. METHODS: Data collected from a computerized MEDLINE search were used for the analysis of the following topics: immediate GI hypersensitivity, oral allergy syndrome, acute urticaria and angioedema, acute bronchospasm, celiac disease, cow's milk enteropathy, dietary protein enterocolitis, breast milk colitis, proctolitis, proctitis, dermatitis herpetiformis, Heiner syndrome, eosinophilic gastroenteritis, atopic dermatitis, asthma, attention-deficit-hyperactivity disorder and behavioral disorders, as well as systems affected by mucosal associated lymphoid tissue-mediated injury of associated lymphoid tissues and the immunologic deviation to Th1 or Th2 mechanisms of FA. CONCLUSIONS: The results of this review allow the construction of a central, unifying hypothesis for a new classification of FA as follows: the clinical manifestations of FA, expressed in affected target organs, may be the result of immunologic injury mediated by interaction of food antigens with contiguous elements of mucosal associated lymphoid tissue. These appear to be modulated by relative imbalances of the Th1/Th2 paradigm, which may be the ultimate determinant governing the expression of FA as IgE-mediated, non--IgE-mediated, or mixed forms of IgE/non-IgE mechanisms of FA.

Dietary Proteins↗
PubMed1997

[Rectal complications of radiotherapy].

Late rectal morbidity has been observed in 2%-25% of patients treated with radiotherapy using curative doses for prostate, cervix and rectal cancers. The major encountered clinical pictures are rectal proctitis, rectal/anal strictures, rectal bleeding, ulcers and fistula. Some may alter the patient's lifestyle while other may induce death. Recommendations concerning the clinical practice are described. The treatment of these late rectal effects include nutritional recommendations, laser, formalin application, and surgery.

Female↗