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PubMed2001

The vasovagal Syncope and pacing (Synpace) trial: rationale and study design.

BACKGROUND: Though vasovagal syncope probably does not directly cause death, it is often associated with severe trauma and, when recurrent, significantly impairs the patient's quality of life. While drug therapy for vasovagal syncope is still controversial, recently two randomized studies revealed the efficacy of dual-chamber pacemaker implantation in decreasing recurrences in very symptomatic patients. However, since both studies were not placebo-controlled, the benefits observed might have been due to the placebo effect of the pacemaker. AIM OF THE STUDY: The aim of the vasovagal Syncope and pacing (Synpace) trial, a multicentre, prospective, randomized, double-blind, placebo-controlled trial, is to ascertain whether, in patients suffering from recurrent vasovagal syncope, the implantation of a dual-chamber pacemaker with rate drop response algorithm programmed to ON, will reduce syncope relapses compared with the implantation of a pacemaker programmed to OFF. Moreover, in order to evaluate the role of the haemodynamic response during tilt-induced syncope in identifying those patients who will benefit most from pacemaker implantation, enrolled patients will be divided into two groups on the basis of their haemodynamic behaviour during tilt-induced syncope: group 1, asystolic response (development of asystole >3 s), and group 2, mixed response (development of bradycardia <60 bpm, without asystole >3 s). The head-up tilt testing protocol will consist of 20 min at 60 degrees without drug potentiation, followed by 15 min at the same inclination after 400 microg of sublingual nitroglycerin. Results from the two groups will be analysed both separately and globally. The primary clinical endpoint of the study will be syncope. INCLUSION AND EXCLUSION CRITERIA: To be enrolled, patients will have to meet the following criteria: at least six syncopal episodes in the patient's lifetime; positive head-up tilt testing with asystolic or mixed response; at least one syncope recurrence following a positive head-up tilt test. The following constitute exclusion criteria: non-vasovagal syncope; other indications for pacing. SAMPLE SIZE: We hypothesize a risk of syncope recurrence of 70% after one year, and we estimate that--owing to the placebo effect alone--pacemaker will produce a 20% decrease in risk, which corresponds to a 50% risk of recurrence after one year, in those patients randomized to 'pacemaker OFF'. We calculate conservatively a risk decrease of 60% in patients with 'pacemaker ON'. This implies a 10% incidence of syncope recurrence after one year, vs 50% in patients with 'pacemaker OFF'. Fifty patients will need to be enrolled in the study: 25 patients for each group.

Databases as Topic↗
PubMed2000

Risk factors for the development of gallstone recurrence following medical dissolution. The British-Italian Gallstone Study Group.

OBJECTIVE: To assess risk factors for gallstone recurrence following non-surgical treatment. DESIGN: A prospective follow-up of a multicentre cohort of post-dissolution gallstone patients. SETTING: Six gastroenterology units in the UK and Italy. PARTICIPANTS: One hundred and sixty-three patients with confirmed gallstone dissolution following non-surgical therapy (bile acids or lithotripsy plus bile acids), followed up by ultrasound scan and clinical assessment at 6-monthly intervals for up to 6 years (median, 25 months; range, 6-70 months). OUTCOME MEASURES: Subject-related variables (sex, age, height, weight, body mass index), gallstone-related variables (number, diameter, presence of symptoms, months to complete stone clearance), treatment modalities (bile acid therapy, extracorporeal shock wave lithotripsy) and follow-up related variables (weight change, use of non-steroidal anti-inflammatory agents, statins, pregnancies and/or use of oestrogens) were assessed by univariate and multivariate analysis as putative risk factors for gallstone recurrence. RESULTS: Forty-five gallstone recurrences were observed during the follow-up period. Multiple primary gallstones and length of time to achieve gallstone dissolution were the only variables associated with a significant increase in the recurrence rate. Appearance of biliary sludge during follow-up was also significantly related to development of gallstone recurrence. Use of statins or non-steroidal anti-inflammatory agents did not confer protection against recurrence. CONCLUSIONS: Patients with primary single stones are the best candidates for non-surgical treatment of gallstones, because of a low risk of gallstone recurrence. The positive association of recurrence with biliary sludge formation and time to dissolution of primary stones may provide indirect confirmation for the role of impaired gallbladder motility in the pathogenesis of this condition.

Adolescent↗
PubMedDate not supplied

[Patients with a complete or partial remission of Major Depressive Episode as part of Recurrent Major Depressive Disorder: description of ECLAIR study population].

Some guidelines and expert consensus consider the way of care management practices for the recurrent depressive disorder, particularly according to different identified risk factors for recurrence. But, few data are available about the way that these risk factors influence the care management of depressive recurrent patients during the partial or complete remission phase. Eclair study is a longitudinal observatory multicentric and national study, which describes the different risk factors that influence the psychiatrist decision about the following of patients suffering form Major Depressive Disorder (at least 3 Major Depressive Episode (MDE) according to DSM IV). This article presents the inclusion data (V0) of patients, with a focus on their demography characteristics and history of trouble, diagnosis, symptomatology evaluation (with CGI-S, HAM-D, Carroll scale and Sheehan scale) and Cloninger's personality questionnaire (TCI). A total of 596 patients with a recurrent depression either on partial remission (PaR) or complete remission (ToR) to their last episode at the selection, have been included. Complete remission was defined by the presence of a maximum of two criteria of MDE (according to DSM IV) excepted depressed mood and diminished interest or pleasure during at least two months with a HAM-D (17 items) score < 7 and partial remission was defined by the persistence of depressed symptoms but not sufficient to complete a diagnosis of MDE (according to DSM IV) associated with a HAM-D (17 items) score between 8 and 13 included. Mean HAM-D scores at V0 were 10.3 +/- 1.6 for PaR group and 4.0 +/- 1.9 for the ToR group. Free time since last episode was 6.5 +/- 10.5 months in ToR group and 11.2 +/- 16.9 months in PaR group (n = 385). Residual symptomatology between prior episodes was systematically present for 47.6% patients in PaR group, and for 26.7% patients ToR group. The feel to have a stressful daily life persisted for 62.5% of patient in PaR group and 34.3% in ToR group; 70.3% patients in PaR group and 57.9% patients in ToR group reported persistence of causal factor. The main collected risk factors for recurrence were the number of prior depressive episodes (64.9%), familial conflict existence (52.9%) and recent events of life (45.1%). In the TCI, a significant difference in comparison with the French normative data has been found for 3 dimensions: Harm Avoidance, Cooperativeness and Self-Directedness. Some differences were obtained for Novelty Seeking, Reward Dependence, and Self-Transcendence, but without sufficient clinical significance.This study confirms various characteristics about the unipolar depressive disorder, particularly the high risk of recurrence in patients with high number of previous episodes. In the research of predictive depressive recurrence signs, it would be interesting to focus on discriminating elements between complete remitted patients and partial remitted patients.

Adult↗
PubMed2002

Surgical treatment of incisional hernia.

BACKGROUND: Incisional hernia is a common complication of abdominal surgery and an important source of morbidity. It may be repaired using open suture, open mesh or laparoscopic mesh techniques. This review examines the results of these methods of repair. METHODS: A Medline literature search was performed to identify articles relating to 'incisional hernia', 'ventral hernia' and 'wound failure'. Relevant papers from the reference lists of these articles were also sought. RESULTS: The recurrence rate after open suture repair may be as high as 31-49 per cent; for open mesh repair it is between 0 and 10 per cent. Comparative studies show that recurrence is significantly more frequent after open suture repair than after open mesh repair; complication rates are similar for both procedures. Recurrence rates after laparoscopic mesh repair vary from 0 to 9 per cent. Comparative studies show that laparoscopic mesh repair is at least as safe and effective as open mesh repair. CONCLUSION: Open suture repair for incisional hernia carries an unacceptably high recurrence rate. The results of open mesh and laparoscopic mesh techniques are encouraging. There is scope for a large multicentre randomized clinical trial to compare laparoscopic and open mesh repair.

Hernia, Ventral↗
PubMed1997

[Comparative study of cibenzoline and flecainide by oral route for preventing recurrence of paroxysmal atrial tachyarrhythmias].

Although paroxysmal atrial arrhythmias are the commonest form of arrhythmia, their therapeutic management still remains controversial. Seventy one patients were included in a multicentre, randomized double-blind, double-placebo study, in parallel groups (37 in group C and 34 in group F) to compare the efficacy of cibenzoline (C) and flecainide (F), administered orally, in the prevention of recurrent atrial arrhythmia. The arrhythmia usually consisted of atrial fibrillation (n = 65), while 6 patients presented with paroxysmal atrial flutter. The mean daily dosages were 221 +/- 60 mg (C) and 165 +/- 49 mg (F). The mean age was 63 +/- 12 years in group C and 63 +/- 16 years in group F. In this trial, atrial arrhythmia was idiopathic in almost two-thirds of cases. The duration of follow-up of this study was 6 months, during which recurrences of arrhythmia were evaluated in terms of the symptoms experienced and in terms of ECG and Holter examinations repeated at the 3rd and 6th months. Supplementary ECG and Holter examinations were also performed in the presence of a clinical suspicion of recurrent symptoms. Comparison of the percentages of patients not developing a documented recurrence and who tolerated treatment, by Kaplan-Meler curves, showed a significant difference between cibenzoline (58%) and flecainide (56%). In the not-responders, the mean time to recurrence was 75 +/- 48 days in group C and 75 +/- 62 days in group F(NS). Six patients dropped out of the trial because of adverse events, including 3 cardiac adverse events (2 case of ventricular proarrhythmic activity). Four extracardiac adverse events led to discontinuation of treatment in group C. In conclusion, the efficacy of cibenzoline and flecainlde in the secondary prevention of atrial arrhythmia was found to be comparable, with 58% and 58% of patients in sinus rhythm, respectively, with a follow-up of 6 months.

Anti-Arrhythmia Agents↗
PubMed1994

A randomised, double-blind, parallel group study to compare subcutaneous interferon alpha-2a plus podophyllin with placebo plus podophyllin in the treatment of primary condylomata acuminata.

OBJECTIVES: The primary objective was to determine if six weeks treatment with subcutaneous interferon alpha-2a (IFN) and podophyllin 25% W/V administered twice per week, preceded by IFN alpha-2a three times weekly for one week showed a greater complete response rate in patients with primary condylomata acuminata when assessed at week 10 than treatment with podophyllin and placebo injections in the same schedule. The secondary objective was to compare recurrence rates in complete responders at six months in the two treatment groups. DESIGN: Randomised, double-blind parallel group study. SETTING: Multicentre study in six genitourinary clinics within the U.K. PATIENTS: One hundred and twenty-four patients with primary anogenital warts. MAIN OUTCOME MEASURES: Complete response rate at week 10, and recurrence rate at week 26 in complete responders. RESULTS: At week 10 analysis of the efficacy population showed complete response in 36% (15/42 patients) of IFN-treated group and 26% (11/43 patients) in the placebo group (no significant difference). Analysis of the safety population at week 26 showed persistence of the complete response in 57% (8/14 patients) of the IFN-treated group and 80% (12/15 patients) of the placebo group (no significant difference). Adverse effects were more common in IFN-treated patients, involved particularly application site reaction and malaise but were generally mild. CONCLUSIONS: At the dose and with the regime described treatment with IFN alpha-2a in combination with podophyllin is no more effective in the treatment of primary anogenital warts than podophyllin alone and is associated with more adverse events.

Adolescent↗
PubMed2001

Multicentric occurrence of hepatocellular carcinoma: diagnosis and clinical significance.

To evaluate current knowledge on the multicentric occurrence (MO) of hepatocellular carcinoma (HCC) and its clinical significance was the purpose of this review. The criteria for MO of HCC are defined as follows: (1) the recurrent tumor consists of well differentiated HCC occurring in a different hepatic segment from moderately or poorly differentiated preexisting HCC, (2) both the primary and recurrent tumors are well differentiated HCC, (3) the recurrent tumors contain regions of dysplastic nodules in peripheral areas and, (4) multiple HCCs, indicating the "nodule-in-nodule" form, in which nodules consisting of moderately or poorly differentiated HCC cells are contained in a nodule of well differentiated HCC cells. However, these criteria assume rare or no metastasis of well differentiated HCC, and are also not applicable to cases in which some HCCs of multicentric origin are rapidly dedifferentiated, presenting morphologic features of moderately or poorly differentiated tumors. Diagnostic methods, besides histopathologic methods, for determining multicentric origin in multiple HCCs in the liver, or recurrent tumor(s) of HCC, include clonal analysis of the integration pattern of hepatitis B virus (HBV) DNA in HBV carrier patients, and analysis of the p53 mutation patterns or loss of heterozygosity of chromosomal DNA. The prognosis of patients with MO of HCC after curative resection is significantly better than that of patients with intrahepatic HCC metastasis. Moreover, the Liver Cancer Study Group of Japan has reported that patients with hepatic resection for small-sized HCCs showed higher survival rates than a nonsurgical treatment group. Consequently, HCC with MO, whether this is synchronous or metachronous, should be surgically removed as the treatment of first choice.

Carcinoma, Hepatocellular↗
PubMed1981

A case of multifocal proliferations of histiocytic cells containing Langerhans' cell granules.

A 61-year-old male was found to have multiple cutaneous nodules, four subcutaneous tumors, and diffuse small nodular lesions of both lungs. The biopsy specimen of the skin lesions revealed a proliferation of histiocytic cells containing Langerhans' cell granules (Birbeck granules). Chemotherapy including vincristine, cyclophosphamide (endoxan), 6-mercaptopurine, and prednisolone (VEMP) for ten weeks improved the skin lesions, some of which disappeared. After resection of all the remaining skin lesions, there was no recurrence. This case seems to be a special type of eosinophilic granuloma or multicentric reticulohistiocytosis.

Eosinophilic Granuloma↗
PubMedDate not supplied

Subclinical ductal carcinoma in situ of the breast: treatment with conservative surgery and radiotherapy.

AIMS AND BACKGROUND: In spite of the fact that ductal carcinoma in situ (DCIS) of the breast is a frequently encountered clinical problem, there is no consensus about the optimal treatment of clinically occult (i.e., mammographic presentation only) DCIS. Interest in breast conservation therapy has recently increased. Few data are available in Italy on the conservative treatment with surgery and adjuvant postoperative radiotherapy. METHODS: A retrospective multi-institutional study was performed in 15 Radiation Oncology Departments in northern Italy involving 112 women with subclinical DCIS of the breast treated between 1982 and 1993. Age of the patients ranged between 32 and 72 years (median, 50 years). All of them underwent conservative surgery: quadrantectomy in 89, tumorectomy in 11, and wide excision in 12 cases. The most common histologic subtype was comedocarcinoma (37%). The median pathologic size was 10 mm (range 1 to 55 mm). Axillary dissection was performed in 83 cases: all the patients were node negative. All the patients received adjunctive radiation therapy with 60Co units (77%) or 6 MV linear accelerators (23%) for a median total dose to the entire breast of 50 Gy (mean, 49.48 Gy; range, 45-60 Gy). Seventy-six cases (68%) received a boost to the tumor bed at a dose of 8-20 Gy (median 10 Gy) for a minimum tumor dose of 58 Gy. RESULTS: At a median follow-up of 66 months, 8 local recurrences were observed, 4 intraductal and 4 invasive. All recurrent patients had a salvage mastectomy and are alive and free of disease at this writing. The 10-year actuarial overall, cause-specific, and recurrence-free survival was of 98.8%, 100%, and 91%, respectively. CONCLUSIONS: The retrospective multicentric study, with a local control rate of more than 90% at 10 years with 100% cause-specific survival, showed that conservative surgery and adjuvant radiation therapy is a safe and efficacious treatment for patients with occult, non-palpable DCIS.

Adult↗
PubMedDate not supplied

[Intraoperative radiotherapy with accelerated electrons for urinary bladder carcinoma: principles and results].

OBJECTIVE: To describe intraoperative radiotherapy with accelerated electrons, a highly selective method of administering irradiation for radical treatment of bladder cancer. METHODS: We reviewed the experience reported in the literature since this treatment modality was utilized in Japan and its application extended to the western countries. RESULTS: Animal experiments have shown an acceptable clinicopathological tolerance to 20 Gy intraoperative irradiation of partial bladder volume. The local recurrence rate was 9% for early solitary tumor (> T2) and 27% for early multicentric tumor, according to the Japanese clinical experience. In the western countries, intraoperative radiotherapy plus external irradiation with or without systemic chemotherapy achieves a pT0 of about 65% (in total cystectomy specimens) and an intravesical tumor control rate of 88% in organ-sparing protocols. CONCLUSIONS: The results achieved by the groups with wider experience demonstrate that highly selective intraoperative radiotherapy is feasible, well-tolerated and effective in terms of inducing complete pathological remissions and definitive control of intravesical tumor. These selected clinical experiences must be corroborated by multicenter studies.

Electrons↗
PubMed1988

Tumor invasiveness and prognosis in resected hepatocellular carcinoma. Clinical and pathogenetic implications.

In order to elucidate the biologic behavior of hepatocellular carcinoma (HCC), the long-term prognostic impact of the pathologic features of 143 surgically resected HCC were studied. Seventy-four were smaller than 5 cm in diameter (small HCC), and 69 were larger (large HCC). This study confirmed that tumor size was an important but not the only determining prognostic factor in HCC. Although cirrhosis could cause hepatic failure, patient mortality was mainly attributable to tumor recurrence, which, in turn, was strongly correlated with the invasive nature of HCC. Tumor invasion to the liver and the intraportal spread were very frequent and particularly extensive in large HCC. In both small and large HCC the noninvasive groups not only had high 4-year actuarial survival (84.6% and 90%, respectively), but there was also no patient mortality from intrahepatic tumor recurrence. Therefore, it was concluded that invasiveness of an HCC is the most crucial factor in determining the long-term outcome for the patient, and that the clinical course of resected HCC is predictable in a great majority of the cases. In our small HCC series only 2.4% of HCC were regarded as having true multicentric origin. These findings suggest that the majority of HCC occur unicentrically, and that multiplicity and tumor recurrence result mostly from intrahepatic dissemination. In both small and large HCCs invasive tumors were accompanied by high patient mortality from tumor recurrence even when the tumor was small, indicating that intrahepatic spread may start very early during the growth of HCC.

Carcinoma, Hepatocellular↗
PubMed2004

Early carotid surgery in acute stroke: a multicentre randomised pilot study.

BACKGROUND: Standard practice has been to delay carotid endarterectomy (CEA) for 2 months following acute stroke to avoid a perceived risk of cerebral haemorrhage. We investigated whether early CEA reduces early recurrent stroke and improves outcome in partial anterior circulation infarction (PACI). METHODS: Patients with PACI and a Barthel score of >18 before stroke underwent carotid duplex and CT imaging within 7 days of stroke. Forty consenting patients fit for surgery with greater than 70% ipsilateral carotid stenosis were randomised, 19 to 'early' (within 24 h) and 21 to 'delayed' surgery (at 8 weeks). Modified Rankin and Barthel scores were recorded at 1 week, 2 months, 6 and 12 months. RESULTS: Rankin scores improved more rapidly following 'early' surgery to a score of 1 (0-4) at 2 and 6 months compared with 2.5 and 2 (1-4), respectively, for delayed surgery (p < 0.05). Barthel scores were also significantly improved following 'early' CEA at 7 days but both groups reached a median score of 20 by 2 months. Four 'delayed' and 3 'early' patients suffered extension or recurrence of neurological deficits with 1 death in each group. CONCLUSIONS: Early CEA within 7 days of ischaemic stroke improved functional outcome with earlier hospital discharge. A large multicentre study is needed to exclude the possibility that 'early' CEA increases the risk of cerebral haemorrhage or death.

Activities of Daily Living↗
PubMed2004

Giant cell tumor of the pelvis and sacrum: 17 cases and analysis of the literature.

The optimal treatment of giant cell tumors of the pelvis and sacrum is controversial. Our current patient series was combined with cases identified in a review of the literature published in the past 50 years, yielding a combined group of 239 lesions for study. Recurrence rates were 49% for patients who had radiation therapy alone, 47% for patients who had surgery with intralesional margins, 46% for patients who had surgery with intralesional margins and radiation therapy, and 0% for patients who had surgery with wide margins. Six percent of patients had benign lung metastases develop, 2% of patients had secondary malignancies, 2% of patients died in the perioperative period, and less than 1% of patients had multicentricity. Radiation-induced sarcoma developed in 11% of patients who received radiation for primary or recurrent lesions. Larger doses of radiation therapy did not decrease the rate of local recurrence. Recurrence after surgery and radiation was not lower than after either treatment alone. Local recurrence was more likely in the patients with sacral tumors (48%) than in the patients with pelvic tumors (34%). Disease status was worse in the patients with sacral lesions (23% died of disease) than in the patients with pelvic lesions (6% died of disease).

Adolescent↗
PubMed1983

[Tomodensitometric study of the course of supratentorial malignant glioma after treatment].

Computed tomography now is the primary method for the management of supratentorial malignant gliomas. In this study, analysis of CT scan controls done at 2 or 3 month intervals in 87 treated patients showed that: 1) in most instances, recurrence arose within the initial tumor site; 2) the tumor invades contiguous anatomical structures through intra-and inter-hemispheric association fibers; 3) multicentric gliomas are uncommon (less than 6% of patients). The purpose of this study was to reduce irradiated volumes and thus radiation toxicity. The finding that most patients experience recurrence within the original tumor site is evidence experience recurrence within the original tumor site is evidence that current radiation doses and total brain irradiation are inappropriate. Our results are consistent with those recently reported in the medical literature. Using computed tomography data, it should be possible to restrict the irradiated volume to the tumor site and to presumptive extension pathways. Higher doses may be delivered to this volume.

Adolescent↗
PubMed1994

Immunoactivation by pidotimod in children with recurrent respiratory infections.

The therapeutic activity and safety of pidotimod ((R)-3-[(S)-(5-oxo-2-pyrrolidinyl) carbonyl]-thiazolidine-4-carboxylic acid, PGT/1A, CAS 121808-62-6), a new synthetic "biological response modifier", were examined in a double-blind, placebo-controlled, multicentre trial in 101 children, including 53 boys and 48 girls aged 2-13 years (mean +/- SD: 4.7 +/- 2.1 years) with a history of recurrent respiratory infections (RRI). Pidotimod (400 mg/day) or placebo were administered orally for 60 consecutive days, followed by a further 60-day follow-up period. The trial was completed by 89.1% of patients. The results indicate that pidotimod has a beneficial effect in children with recurrent respiratory infections: the percentage of patients presenting symptoms affecting the upper and lower airways was significantly lower after treatment with the active drug than after treatment with placebo. Relevant side effects were not reported during the trial. An evaluation of the expression of CD25 (after in vitro stimulation of circulating mononuclear cells with PHA) before and after treatment with the two products revealed a significant increase in CD25+ cells in the group treated with pidotimod but not in the group treated with placebo.

Adjuvants, Immunologic↗
PubMed1997

Detection with MR imaging of residual tumor in the breast soon after surgery.

OBJECTIVE: Difficulties in the preoperative assessment of tumor size and extent result in a positive pathologic margin in up to 70% of patients undergoing breast conservation surgery. Although positive margins usually require reexcision, the location and extent of surgery required are often difficult to establish by current imaging techniques. We investigated the accuracy of three-dimensional rotating delivery of excitation off resonance (3D RODEO) MR imaging of the breast in revealing the presence and extent of residual tumor within the breast soon after surgery. MATERIALS AND METHODS: Nineteen patients who had undergone lumpectomy or excisional biopsy were evaluated with contrast-enhanced 3D RODEO MR imaging of the breast within 10 months after surgery. The MR imaging results were correlated with serial-sectioned mastectomy or partial mastectomy specimens from 18 patients and with a clinical and mammographic follow-up examination in one patient. RESULTS: We found that 3D RODEO MR imaging accurately revealed the presence or absence and the location and extent of recurrent tumor in 15 of the 18 patients who had pathologic confirmation. Of the three MR imaging-pathology mismatches, two had irregular or nodular enhancement that corresponded to microabscesses. The third mismatch showed multicentric disease on MR imaging but only single-quadrant lobular carcinoma at pathologic examination. Our 19th patient showed no evidence of recurrent tumor on MR imaging or at 2-year follow-up clinical and mammographic examinations. CONCLUSION: MR imaging with 3D RODEO technique correctly revealed the presence or absence, the location, and the extent of recurrent tumor in 84% of patients who had recently undergone breast surgery.

Biopsy↗
PubMed1994

Treatment with coumarin to prevent or delay recurrence of malignant melanoma.

Both coumarin (1,2-benzopyrone) and warfarin (4-hydroxycoumarin) have been shown to prevent the recurrence of malignant melanoma. Their action is macrophage-dependent and the dosage is critical. In 1984 a multicentre, prospective, randomised, double-blind trial of coumarin, given as a daily 50-mg dose for 2 years after surgery in patients with high-risk melanoma, was started. the patients had lesions greater than 1.70 mm thick and TNM stage IB or stage II disease. To date there are 4 recurrences in the coumarin-treated group of 13 patients, and 10 recurrences in the placebo-treated group of 14 patients (P < 0.01). There were no toxic effects.

Chemotherapy, Adjuvant↗