Surgically staged high-risk endometrial cancer: randomized study of adjuvant radiotherapy alone vs. sequential chemo-radiotherapy.

OBJECTIVE: Our purpose was to establish whether platinum-based chemotherapy combined with standard surgery and radiotherapy will improve overall and disease-free survival and lower the recurrence rate in patients with high-risk endometrial cancer. STUDY DESIGN: A total of 156 patients with Stage IA-B Grade 3 (n=28), or Stage IC-IIIA Grade 1-3 (n=128) were postoperatively randomized to receive radiotherapy (56 Gy) only (Group A, n=72) or radiotherapy combined with three courses of cisplatin (50 mg/m(2)), epirubicin (60 mg/m(2)) and cyclophosphamide (500 mg/m(2)) (Group B, n=84). RESULTS: The disease-specific overall five-year survival was in Group A 84.7% vs. 82.1% in Group B (p=0.148). The median disease-free survival in A was 18 (range 9-36) months and 25 (range 12-49) months in B (p=0.134), respectively. During a five-year follow-up 32 patients relapsed. Of the recurrences 5 were local and 20 distant, while 7 were combined. As calculated from the operation, the median time to recurrence was 15 (range 6-37) months in Group A, and 20 (range 8-60) months in Group B, respectively (p=0.170). Twenty-six patients died of the disease during the five-year follow-up, 11 in A and 15 in B. The patients succumbing in A lived a median 23 (range 15-44) months as compared to 37 (range 13-50) months in B (p=0.148). Chemotherapy was associated with an acceptable rate of acute toxicity. Less than 8% of the patients complained of Grade 3/4 nausea. The rate of Grade 3/4 leucopenia was at the highest at 16.6% during the third cycle but only 6.2% of the patients had Grade 3 infection. A total of 10 patients developed intestinal complications demanding surgery, 2 in Group A (2.7%) and 8 (9.5%) in Group B, respectively. CONCLUSION: Adjuvant chemotherapy with cisplatin, epirubicin and cyclophosphamide failed to improve overall survival or lower the recurrence rate in patients operated on and radiated for high-risk endometrial carcinoma. Chemotherapy was associated with a low rate of acute toxicity but appeared to increase the risk of bowel complications.

Long-term results of transmetacarpal replantation.

UNLABELLED: The aim of this study was to evaluate subjective, functional and occupational outcome after transmetacarpal amputations. PATIENTS AND METHODS: Forty-three patients (mean age 34, range 1-71) with a transmetacarpal injury devitalizing three or more finger rays were treated with revascularization (22 patients) or replantation (21 patients). Most of the injuries (60%) were caused by a circular saw. Altogether 174 rays were injured of which 14 were doomed unsalvageable. An attempt was made to save the rest (n=160). Metacarpals were shortened on average 8 (range 0-22)mm. The number of arteries repaired varied from 2 to 5 and a vein graft was used in 16 patients. Thirty-eight patients (88%) attended a clinical follow-up examination performed by an independent observer at mean 9 years (range 2-24 years) after the injury. Subjective result was documented. Sensation was tested by two-point discrimination and Semmes-Weinsten filaments. Total active motion of MP- and IP-joints was measured. Grip and pinch strength was recorded. Functional results were assessed by Tamai's and Chens scoring systems. Cold intolerance and occupational history was registered. RESULTS: Primary survival of the replanted or revascularized digital rays was 86% (137/160). Subjective result was excellent in 11, good in 11, fair in 10 and poor in 6 patients. Out of 110 revascularized/replanted digits 86 (78%) achieved 2PD, among those the mean 2PD was 14.7 mm (range 6-25 mm). Total active motion (TAM) was on average 154 degrees (range 20-270 degrees ) per injured digit. The mean grip strength measured 56% (range 3-100%, n=33) and pinch strength 58% (10-100%, n=30) of the uninjured side. Using Tamai's scoring system the outcome was excellent in eight, good in 11, fair in 12 and poor in seven patients. According to Chen's criteria the result was excellent in seven, good in eight, fair in 18 and poor in five patients, respectively. The majority experienced cold intolerance. Sixteen of the 30 manual workers resumed to their previous or related occupation, ten were re-educated and four retired. CONCLUSIONS: The majority of transmetal carpal injuries with devascularized rays can be revascularized/replanted with a good subjective and satisfactory functional end result. Most patients can resume their old occupations or be employed after re-education.

Ultrasonographic-guided pervaginal cul-de-sac cytology in the follow-up of ovarian carcinoma.

UNLABELLED: The aim of this study was to compare, prospectively, traditional pervaginal cul-de-sac aspiration cytology with an ultrasonographic-guided aspirate in the detection of residual or recurrent ovarian carcinoma. PATIENTS AND METHODS: Fifty-one patients with ovarian carcinoma were monitored during chemotherapy (21 patients) or follow-up (30 patients) after first-line treatment. All patients underwent both traditional blind pervaginal cul-de-sac aspiration cytology and an ultrasonographic-guided pervaginal aspirate. The samples were classified as class 0 or insufficient when no mesothelial cells were detected in the aspirate. The results of cytological classification of the aspirates were compared with each other according to sampling order. RESULTS: Samples were classified as class 0 in 56% when the traditional cul-de-sac aspiration was taken first, and in 73% when ultrasonographic-guided aspiration was taken first (p = 0.249, Fisher's exact test). The number of class 0 samples was smaller among those taken second than among those taken first (22 (44%) vs. 33 (65%), p = 0.046). Four recurrences were detected during the mean follow-up of six months (range 2-11 months) in 30 patients who were followed-up after the first-line treatment. In one case, a positive cul-de-sac cytology was the first and only early indication of recurrence. CONCLUSION: The use of ultrasonography did not improve the accuracy of the cul-de-sac aspiration. The greater amount of fluid in the cul-de-sac during the second sampling might contribute to achieving a better result.

A randomised phase III study comparing high-dose chemotherapy to conventionally dosed chemotherapy for stage III ovarian cancer: the Finnish Ovarian Cancer (FINOVA) study.

Women with stage III ovarian cancer and with < or = 2 cm residual tumour were randomly assigned to receive either conventionally dosed chemotherapy (group A) or HDCT (group B). Patients allocated to group A received 6 cycles of paclitaxel (T) 135 mg/m2 and cisplatin (P) 75 mg/m2 every 3 weeks, and those allocated to HDCT received 3 TP cycles followed by peripheral blood stem cell mobilisation with cyclophosphamide (C) 3000 mg/m2 and T 175 mg/m2, and subsequently HDCT with carboplatin 1500 mg/m2, C 120 mg/kg, and mitoxantrone 75 mg/m2. The trial was closed early after 42 patients were entered due to slow accrual. The median follow-up time of patients who were alive was 81 months. The median progression-free survival time was 15.9 and 16.6 months (hazard ratio, HR 0.83; 95% CI 0.41-1.69, P = 0.61) and the median overall survival time was 43.7 and 64.3 months (HR, 0.74; 95% CI 0.34-1.61, P = 0.44) in groups A and B, respectively. Although one patient died of HDCT-related toxicity, the regimen was otherwise relatively well tolerated. We conclude that the HDCT regimen used was feasible, but did not result in significantly improved survival in this prematurely closed trial. A clinically important survival benefit cannot be excluded due to the small sample size.

Response of estrogen receptor-positive intraabdominal fibromatosis to aromatase inhibitor therapy.

BACKGROUND: Intraabdominal fibromatosis is a rare tumor-like lesion of uncertain etiology. CASE: A 49-year-old woman underwent abdominal hysterectomy and bilateral salpingooophorectomy in 1997 to treat uterine leiomyomata and ovarian fibromatosis. Postoperatively, she received estradiol 2 mg daily as hormone replacement therapy (HRT). In 2000, laparotomy performed for a large pelvic tumor revealed inoperable intraabdominal fibromatosis. The tumor, which was positive for estrogen and progesterone receptors, resolved during aromatase inhibitor therapy. The first follow-up computed tomographic (CT) scan revealed that the tumor masses were significantly reduced in size, and successive CT scans revealed stable disease. CONCLUSION: Intraabdominal fibromatosis that expresses estrogen and progesterone receptors may respond favorably to treatment with aromatase inhibitors.

Hematological toxicity of salvage treatment after high-dose chemotherapy and conventional chemotherapy of ovarian cancer.

BACKGROUND: To compare the toxicity of salvage chemotherapy (CT) given for recurrent or progressive ovarian cancer (OC) after either high-dose chemotherapy (HDC) or conventional CT. PATIENTS AND METHODS: HDC supported by autologous stem cell transplantation was given to ten OC patients. Seven of them were treated with salvage CT for recurrent disease and were included in this study (Group A). Seven patients with recurrent OC treated primarily with conventional CT (Group B) were matched for age (+/- 3 years), stage and histology. The hematological toxicity of treatment was graded according to the WHO criteria. RESULTS: During salvage CT, grade 3-4 neutropenia was seen in nine out of 81 courses (11.1%) in Group A and in six out of 85 courses (7.1%) in Group B (p <0.1). The use of G-CSF was more common in Group A than in Group B, both during first-line and salvage CT. When the mobilisation courses were excluded in Group A, the use of G-CSF was more common during salvage treatment than during primary treatment (27 out of 81 vs. 16 out of 85, p < 0.05). Also, in Group B the use of G-CSF was more common during salvage CT than during primary treatment (10 out of 85 vs. 0 out of 73, p < 0.01). Grade 3-4 thrombocytopenia was seen in nine out of 81 courses (11.1%) in Group A but in none of the 85 courses (0%) in Group B (p<0.05). No platelet transfusion was needed during salvage treatment. The mean interval of courses in salvage CT was 27.7 days (range 19-71) in Group A and 27.5 days (range 18-120) in Group B (p = ns). Overall survival was 40.4 months in Group A and 33.0 months in Group B (p < 0.1). CONCLUSION: Salvage treatment after HDC was well-tolerated when given with G-CSF support. Salvage chemotherapy could be carried out with the same doses and intervals both for patients treated earlier with HDC and conventional CT.