Survival after groin dissection for malignant melanoma.

Groin dissection was performed in 158 patients with malignant melanoma (superficial dissection, 76 patients; radical dissection, 82 patients). Of 63 patients with palpable nodes, 57 patients (90%) had histologic involvement. Of 93 patients with nonpalpable nodes, 31 patients (33%) had histologically positive nodes. The 5-year survival rate for patients with histologically negative nodes (n = 69) was 77%; the 5-year survival rate for patients with histologically positive nodes (n = 89) was 43%. The respective 5-year disease-free survival rates were 72% and 34%. Of 57 patients with palpable, positive inguinal nodes, 21 patients (37%) had involvement of the deep nodes. Of 31 patients with nonpalpable, histologic involvement of the inguinal nodes, six patients (19%) had or developed involvement of the deep nodes. One of two patients with uncertain clinical status of the nodes preoperatively had positive deep nodes. In prophylactic node dissection, frozen section of the inguinal group of the nodes does not provide a reliable method, because of sampling errors, in determining microscopic involvement of the nodes and in deciding whether a superficial or radical groin dissection is to be done. For patients with positive nodes the 5-year survival rate was 48% when only the inguinal group was involved and was 28% when both inguinal and deep nodes were involved; the respective 5-year disease-free survival rates were 39% and 20%. Survival after therapeutic groin dissection may partly depend on the thoroughness of the procedure. Patients who have positive, deep nodes and who are undergoing an incontinuity dissection of the inguinal, iliac, and obturator nodes have an appreciable 5-year survival rate.

Periodontal disease in non-insulin-dependent diabetes mellitus.

The relationship between diabetes mellitus and oral health status was determined in Pima Indians from the Gila River Indian Community in Arizona. This tribe of native Americans has the world's highest reported incidence and prevalence of non-insulin-dependent (type 2) diabetes mellitus. The probing attachment level, alveolar bone loss, age, sex, Calculus Index, Plaque Index, Gingival Index, fluorosis, and DMFT as well as the diabetic status was assessed in 1,342 Pima Indians who were at least partially dentate. The prevalence and severity of destructive periodontal disease was determined by measuring probing attachment loss and radiographically apparent interproximal crestal alveolar bone loss, two independent but correlated indicators of periodontal destruction. Only diabetic status, age, and the presence of subgingival calculus were significantly associated with both increased prevalence and greater severity of destructive periodontal disease in this population. Diabetic status was significantly and strongly related to both the prevalence and severity of disease after adjusting for the effects of demographic variables and several indices of oral health including the Plaque Index. Subjects with type 2 diabetes have an increased risk of destructive periodontitis with an odds ratio of 2.81 (95% confidence interval 1.91 to 4.13) when attachment loss is used to measure the disease. The odds ratio for diabetic subjects was 3.43 (95% confidence interval 2.28 to 5.16) where bone loss was used to measure periodontal destruction. These findings demonstrate tht diabetes increases the risk of developing destructive periodontal disease about threefold. Furthermore, diabetes increases the risk of developing periodontal disease in a manner which cannot be explained on the basis of age, sex, and hygiene or other dental measures.(ABSTRACT TRUNCATED AT 250 WORDS)

Limb salvage in soft tissue sarcomas with selective combination of modalities.

One hundred and seventy-one consecutive patients with soft tissue sarcomas were treated in the period 1977-1986. Of 144 patients with extremity sarcomas, only eight (6%) were managed with amputation. The overall estimated 5-year survival rate is 64%, and that for patients with extremity tumors is 71%. The 5-year local recurrence rate in extremity sarcomas was 6% for patients with minimum surgical margins 2 cm or greater and no further local therapy, and 6% for those with narrower surgical margins and adjuvant postoperative radiation; 80 patients (56%) were in the former group and 64 (44%) in the latter. With a selective combination of modalities, limb salvage can now be practiced in 94% of the patients with acceptable local control and survival rates.

Axillary node dissection in malignant melanoma: results and complications.

Axillary node dissection was performed in 133 patients with malignant melanoma. The nodes were histologically negative for disease in 67 patients and positive in 66 patients. Disease-free survival rate varied according to the histologic and clinical status of the nodes and to the number of the nodes involved by tumor. The lymphocele rate was 7%; the wound infection rate was 5%; and the skin edge necrosis rate was 0.8%. One patient (0.8%) experienced both lymphocele and wound infection. Neurapraxia developed in the distribution of the musculocutaneous nerve in two patients (2%); this resolved completely in 3 to 4 weeks and was not observed again, since hyperextension of the arm has been carefully avoided during the procedure. Transient arm edema was noted postoperatively in five patients (4%), and the edema responded promptly and completely to elevation of the arm for 1 to 2 weeks. There was no permanent edema even after ligation and resection of the distal portion of the axillary vein (six patients). Permanent arm edema has not developed in any of the 133 patients, indicating that axillary node dissection as performed for malignant melanoma is not associated with the long-term complications occurring after mastectomy and axillary node dissection.

Common problems with statistical aspects of periodontal research papers.

Enormous advances have been made over the past decade concerning the proper use of statistical techniques in reporting periodontal research. However, numerous articles still appear which use inappropriate or less than optimal statistical methods. This paper describes the most common problems encountered in a recent review of the literature, and presents suggestions which will hopefully improve the quality of statistical information reported in future research articles.

Variants of hemipelvectomy and their complications.

In the period from 1976 through 1986, 62 procedures were performed. Of these, 42 were posterior flap hemipelvectomies, 5 anterior flap hemipelvectomies, and 15 internal hemipelvectomies. The median duration of these procedures was 6.5 hours, and the median blood loss was 2,541 ml. Postoperatively, there were no wound problems in 38 procedures (61 percent). The overall rate of flap necrosis was 15 percent, and the overall rate of wound infection, 17 percent. The viability of the posterior flap was not dependent on the level of division of the iliac vessels. By leaving the gluteus maximus muscle attached to the posterior flap, the rate of flap necrosis, initially 55 percent, was eliminated completely in the last 38 patients. Including 11 recently performed procedures, the operative mortality rate was 1 percent (1 of 73 procedures). For patients operated on with curative intent, the estimated 5-year survival rate was 43 percent.

Soft-tissue sarcomas of the proximal lower extremity.

Of 54 patients with soft-tissue sarcomas of the proximal part of the lower extremity, 2 patients (4%) were treated with amputation, while 52 patients (96%) were treated with limb-preserving resection. Adjuvant postoperative irradiation was applied selectively when the minimum margin was less than 2 cm (22 patients). Technical improvements in exposure, resection of involved vessels or nerve, and preservation of function permitted a high rate of limb salvage with satisfactory function. At a median follow-up of 30 months for those subjects still alive, the 5-year disease-free survival rate was 65%, and only 3 patients (6%) had had a local recurrence.

Clinical factors and treatment parameters affecting prognosis in adult high-grade soft tissue sarcomas: a retrospective review of 267 cases.

Data on 267 adults with high-grade soft tissue sarcomas were reviewed. Male sex, large tumor size, Stage IIIC, IV A and sarcomatous skin invasion, as well as marginal excision, amputation, postoperative fever and wound infection, were found to be associated with shorter survival time. Head and neck location, multifocal growth of sarcoma. Stage IIIC, malignant skin infiltration, locally recurrent tumor as well as marginal excision and limb-sparing resection, were found to influence local control unfavorably in single factor analyses. Each of the significant variables were entered into a multivariate proportional hazards model in a stepwise manner. Stage, postoperative fever, the surgical margin and type of surgery, and sarcomatous skin changes significantly affected survival time. Local recurrence was significantly affected by the surgical margin and type of surgery, the status of tumor (primary or recurrent), stage and malignant skin infiltration.

Hydroxyurea plus pelvic irradiation versus placebo plus pelvic irradiation in nonsurgically staged stage IIIB cervical cancer.

Twenty-five patients with FIGO stage IIIB carcinoma of the cervix were entered into a prospective, double-blinded randomized study to evaluate the possible radiation potentiating properties (i.e., improved survival) of the S phase cell cycle specific inhibitor of DNA synthesis hydroxyurea (H). In contrast to our previous randomized trial of patients with FIGO stage IIIB carcinoma of the uterine cervix who were documented to be without paraaortic lymph node metastasis by pretherapy staging paraaortic lymphadenectomy [Piver et al.: J Surg Oncol 35: 129-134, 1987], these patients either refused surgical staging or, because of medical conditions, could not undergo pretherapy paraaortic lymphadenectomy. Patients were to receive 6,000 cGy/6 weeks to the pelvis by megavoltage radiation therapy followed by 2,500 cGy to point A by intracavitary and vaginal radium/cesium. The median pelvic cGy for the Hu patients was 5,967 cGy and for the placebo patients 6,013 cGy. Leukopenia (WBC less than 2,500/mm3) significantly increased in patients given hydroxyurea as compared with those given placebo (P less than 0.0001). There was no statistically significant difference relative to anemia, thrombocytopenia, radiation skin reactions, diarrhea, or radiation induced complications requiring surgical correction. The estimated 5 year disease-free interval was 54% for the hydroxyurea patients (median not reached) and 18% for the placebo patients with a median of 11 months. Because of these results, those of our previous reports, and those of the Gynecologic Oncology Group, we believe that hydroxyruea plus pelvic radiation should be the standard against which new potential radiation sensitizers are tested.

Tumor thickness and prognosis in clinical stage I malignant melanoma.

The current grouping of patients with malignant melanoma into thin, intermediate, and thick melanomas provides a convenient but arbitrary classification which, although providing "average" survival values for each group, offers crude prognostication for the individual patient. A review of 371 patients with clinical Stage I malignant melanoma, treated during the period 1970 to 1985, was conducted. The estimated 5-year survival rate for female patients with melanomas 1.0 mm thick was 94%; for each 1-mm increment in thickness the survival rate declined by about 3%, up to the 6 mm mark, the survival rate declining thereafter by about 8% for each additional millimeter in the range of 7 to 15 mm of thickness. The estimated 5-year survival rate for male patients with melanomas 1.0 mm thick was 80%; for each 1-mm increment the survival rate declined by about 9%, up to the 10 mm mark. The proposed method of estimating the expected survival according to the patient's sex and the thickness of the primary lesion hopefully provides a more accurate and convenient method of prognostication for the clinician dealing with specific patients with intermediate or thick melanomas.

Cancer mortality in a northeastern native American population.

This study compared cancer mortality among the Seneca Nation of Indians (SNI) between 1955 and 1984 with cancer patterns exhibited by the general population of New York State (NYS), exclusive of New York City. Cancer mortality among the SNI was compared with cancer mortality in NYS using age and sex standardized mortality ratios (SMR). Deficits in overall cancer mortality were noted among both SNI males (SMR = 78) and females (SMR = 73). Results from this investigation will contribute to the understanding of patterns of malignant disease mortality among native peoples and may be of benefit for monitoring the impact of cancer mortality among the SNI and other Native American groups.

Cancer surveillance in a northeastern native American population.

This study compares cancer incidence among the Seneca Nation of Indians (SNI) between 1955 and 1984 with cancer incidence patterns exhibited by the general population of New York State (NYS), exclusive of New York City. The cohort for this study consisted of all members of the SNI enrolled on January 1, 1955 and residing in NYS (N = 3262). Cancer incidence among the SNI is compared with cancer incidence patterns in NYS using age and sex standardized incidence ratios (SIR). Decreased cancer incidence was observed for all sites combined with SNI males exhibiting 64% of expected incidence and females exhibiting 53% of expected incidence. Although incidence deficits were observed for several sites, cancer incidence was not significantly elevated for any cancer site. Results from this investigation will contribute to the understanding of patterns of malignant disease among native peoples and aid in directing cancer control programs and services available to native groups.

Distributional shape of nutrition data.

Nutrition data from 111 undergraduate college students (51 males and 60 females, ranging in age from 17 to 24) were studied with respect to the shape of the underlying probability distributions. Three-day averages for total energy, percent protein, percent saturated fat, percent unsaturated fat, percent complex carbohydrates, percent refined carbohydrates, cholesterol, sodium, vitamin C, and iron (measured in milligrams) were computed, and their distributions were compared with the normal (Gaussian) distribution. The distribution of values of sodium for females and, to a lesser extent, cholesterol for females and of cholesterol and vitamin C for males, differed from the normal distribution. The remaining distributions appeared to be reasonably close to normal in shape. It is recommended that nutrition researchers verify the normal distribution assumptions prior to applying parametric techniques to their data and that they use nonparametric (distribution-free) techniques to analyze their data whenever those assumptions are not valid.

Mortality in a northeastern Native American cohort, 1955-1984.

Patterns of mortality among members of the Seneca Nation of Indians between January 1, 1955, and December 31, 1984, were investigated. The study cohort consisted of all members of the Seneca Nation residing in New York State who were listed in the tribal rolls as of January 1, 1955 (n = 3,262). Deaths among cohort members were identified through a computer match against New York State vital records files. Sex-specific standardized mortality ratios (SMRs) were calculated on the basis of mortality patterns exhibited by the general population of New York State, exclusive of New York City. Seneca Nation males demonstrated an excess of deaths from all causes (SMR = 124), while all-cause mortality among Seneca Nation females did not differ from that expected (SMR = 106). Both males and females exhibited excess mortality from infectious diseases, diabetes mellitus, cirrhosis of the liver, and accidents and injuries. Excess mortality was also noted among males for deaths due to atherosclerosis and hernia/intestinal obstruction and among females for deaths due to pneumonia, chronic nephritis, and homicide. Both sexes exhibited a deficit of deaths due to malignant neoplasms and circulatory diseases. Findings from this study will be useful to those responsible for the planning and implementation of health care programs among the Seneca Nation of Indians and other Native American groups.

Required duration and power determinations for historically controlled studies of survival times.

This paper provides power formulae for historically controlled studies with survival time endpoints, and considers two designs. The first design involves no further follow-up of control group subjects; the second design involves collection of additional information on control group subjects who had not failed at the time of design of the prospective portion of the study. The power functions differ from those for concurrently controlled studies, since, under the first design, the control group data are constant for purposes of power calculations, while under the second design, some of the control group data are constant while the remainder are random. I contrast the required duration of these studies with the required duration for comparable concurrently controlled studies under a wide range of conditions.

The effect of local recurrence on survival time in adult high-grade soft tissue sarcomas.

Data gathered on 262 adults with high-grade soft tissue sarcoma, operated on at the same institution for curative intent, were used to study formally, and to quantitate for the first time, the relationship between local recurrence of the tumor and survival time. Using Cox's proportional hazards model with a time-dependent covariate representing the local recurrence of the tumor, it was found that local recurrence is significantly associated with a shorter survival time (estimated relative risk (relative hazard) = 2.5, p less than 0.0001). The estimated 5 yr survival rate and median survival time for patients without a local recurrence were 44% and 42 months, respectively, while the corresponding figures for patients with a local recurrence were only 26% and 28 months. Hence, a local recurrence resulted in a relative decline in the estimated 5 yr survival rate of 41%. This strong relationship continued to hold even after adjusting for several other important, time-independent prognostic variables (stage, type of surgery, type of resection, signs of sarcomatous skin invasion, and presence of postoperative fever) in a multivariable analysis. Local control of high-grade soft tissue sarcomas is vitally important for successful management of these patients.

Surgically documented response to intraperitoneal cisplatin, cytarabine, and bleomycin after intravenous cisplatin-based chemotherapy in advanced ovarian adenocarcinoma.

Thirty-one evaluable patients with stages III and IV invasive ovarian adenocarcinoma were treated on a phase II protocol of second-line intraperitoneal cisplatin, cytarabine, and bleomycin. All 31 patients received first-line intravenous (IV) cisplatin-based chemotherapy; the size of the residual cancer was documented surgically before intraperitoneal chemotherapy in all patients. Response to intraperitoneal chemotherapy was documented by a third-look laparotomy in all patients not evidencing progression of disease clinically. There were eight responses (26%): five surgical complete responses and three surgical partial responses. Responders were patients with stage III ovarian cancer, small residual disease of less than or equal to 1 cm (primarily less than or equal to 5 mm), and patients who previously had responded to cisplatin-based IV chemotherapy. Of the 15 patients with stage III ovarian cancer, residual disease less than or equal to 1 cm, and those who had responded to first-line IV cisplatin-based chemotherapy, 53% (eight) responded to second-line intraperitoneal chemotherapy. Intraperitoneal chemotherapy as used in this phase II protocol would appear to be an effective second-line treatment in advanced ovarian cancer in this specific subset of patients.

Tumor size/symptom duration ratio as a prognostic factor in patients with high-grade soft tissue sarcomas.

Two hundred sixty-seven patients with high-grade (G2,G3) soft tissue sarcomas but without distant metastases, were studied retrospectively with respect to their duration of symptoms and size of tumor. Prognosis was significantly related to the size of the tumor (P = 0.0039). Small tumors (5 cm or less) had a 5-year survival rate of 49% compared to 28% for large tumors (more than 5 cm in diameter). Symptom duration was not related significantly to survival time (P = 0.2490). The ratio of the size of the tumor (greatest diameter, recorded in cm) to duration of symptoms (recorded in months), reflecting the growth rate of the tumor, is introduced as a potentially important prognostic variable. Analysis revealed a highly significant relation between an increasing size/duration ratio and shorter overall survival time (P less than 0.0001) and time to distant metastases (P = 0.0034). Moreover, an optimal cut-off point of 1.0 for the size/duration ratio offers prognostic information independent of the G-TNM classification and other prognostic factors.

Five and ten year estimated survival and disease-free rates after intraperitoneal chromic phosphate; stage I ovarian adenocarcinoma.

From 1975 to 1982, 25 evaluable patients with FIGO Stage I ovarian cancer were treated with intraperitoneal chromic phosphate (32P). All patients underwent total abdominal hysterectomy, bilateral salpingo-oophorectomy with (28%) or without (72%) omentectomy, with no other surgical staging procedures prior to referral. Patients were restaged by laparoscopy (inspection of diaphragms, abdomen, and pelvis), biopsy of suspicious lesions, and peritoneal cytologic washings prior to intraperitoneal chromic phosphate therapy. For the 25 patients, the estimated 5- and 10-year recurrence-free rates and the 5- and 10-year survival rates are 84% and 75%, respectively. Excellent 10-year recurrence-free rates were achieved for Stages IA and IC, nonruptured cysts, and Grade I and II tumors. In contrast, very low 10-year survival rates were achieved for patients with Stage IB, ruptured cysts, or Grade III tumors.

Prognostic significance of lymph node metastasis and bone, major vessel, or nerve involvement in adults with high-grade soft tissue sarcomas.

Two hundred sixty-seven patients with high-grade (G2 or G3) soft tissue sarcomas (STS) were examined. All tumors were removed by resection (marginal or wide) or amputation. Seventy-four patients had T3 primary tumors invading neurovascular structures (n = 41) or bone (n = 33), and 29 patients had histologically confirmed metastases to the regional nodes removed at the time of definitive surgery. The estimated 5-year and 10-year survival rates for patients in Stage IIa, b or IIIa, b were 44% and 37%, respectively. For patients with neurovascular or bone invasion the survival rates were 24% and 15%, respectively. For patients with lymph node metastases the survival rates were 10% and 3%, respectively. Survival of patients with primary sarcomas invading the nerve, vessel, or bone was significantly better than that of patients with lymph node metastases (P = 0.002). Survival also was distinctly different between patients with nerve or vessel invasion who had a 5-year survival rate of 32%, and patients with bone invasion who had a 5-year survival rate of 15% (P = 0.002). These findings suggest that the current staging system for STS should be reexamined. Also, patients with nerve or vessel invasion should be assigned a IIIc1 position, those with bone invasion a IIIc2 position, and those with lymph node metastases a IVa position in the staging system.