Clinical study on the efficacy of LED phototherapy for pain control in an orthodontic procedure.

Pain is an unpleasant and emotional subjective sensory experience that occurs during orthodontic procedures. Currently, LED phototherapy is an alternative to the use of laser light as analgesic agent due to similarity of response and lower cost. This case-control, quantitative, qualitative, and longitudinal study aimed to investigate the effect of IR LED phototherapy (λ846 ± 20 nm) in pain during the process of tooth separation during orthodontic treatment. After approval by the Institution Ethics Committee, 40 patients (30 female/10 male, 20-30 years old, average age 24.5 ± 2.6 years old) fulfilling the inclusion criteria entered the study and received a set of four visual analog scales (VAS) for scoring pain immediately, 48 h, 72 h, and 7 days after the insertion of the separating elastics. The patients were randomly distributed into two groups (experimental and control). The patients of experimental group received LED phototherapy (180 mW, 22 s, 4 J, 8 J/cm2, 0.36 W/cm2, spot of 0.5 cm2, spot diameter 0.8 cm) at the same times in which VAS was performed, and control patients were not irradiated. It was found that, in both groups, there was an increase in pain 48 h after insertion of the elastic tooth separator, decreasing 72 h after its installation and reached the lowest level of pain after 7 days. Comparison between groups showed that pain level in the LED group was always statistically significantly lower (p < 0.05), except for the time of installation (T1). The use of LED light was effective in significantly reducing the level of pain after insertion of the elastic tooth separators when compared to the control group.

Determinants of severity of menopausal symptoms among Saudi women in Riyadh city.

OBJECTIVE: To determine the relationship between sociodemographic, reproductive and lifestyle factors and the severity of menopausal symptoms among Saudi women attending a university hospital in Riyadh city. METHODS: A cross-sectional survey was carried out during 2010 in Riyadh city. Women aged > 40 years attending or accompanying their relatives in outpatient clinics in King Khalid University Hospital were invited to participate in the study. The English version of the Menopause Rating Scale (MRS) was used to assess the severity of menopausal symptoms after translation and validation on a sample of 30 women. RESULTS: A total of 490 women were included. Severe urogenital symptoms were more common among housewives compared to working women (odds ratio (OR) 2.27, 95% confidence interval (CI) 1.12-4.68) and women living in apartments or small houses compared to women living in villas (OR 1.70, 95% CI 1.90-2.64). Nulliparous women had more severe somatic symptoms compared to those who had been pregnant (OR 2.83, 95% CI 1.10-7.69). Women who exercised regularly were less likely to experience severe somatic and urogenital symptoms (OR 0.57, 95% CI 0.37-0.86; OR 0.65, 95% CI 0.44-0.98, respectively). Obese women experienced more severe psychosomatic symptoms compared to those of normal body mass index (OR 2.01, 95% CI 0.96-4.93). CONCLUSION: Women who are housewives, living in apartments, not exercising regularly and obese are more likely to suffer from severe symptoms of menopause.

Serum levels of adrenomedullin and inflammatory cytokines in women with term idiopathic intrauterine growth restriction.

This study aimed to determine the concentrations of adrenomedullin (AM), tumour necrosis factor (TNF)-α and interleukin (IL)-6 in maternal circulation of full-term idiopathic intrauterine growth restriction (IUGR) in relation to appropriate-for-gestational-age (AGA) and the possible correlation of AM to these cytokines. A case-control study included 50 idiopathic IUGR mothers and 25 AGA, who were evaluated regarding their serum levels of AM, TNF-α and IL-6. We found that women with idiopathic IUGR have significantly higher serum levels of AM, TNF-α and IL-6 (p = 0.008; 0.016; 0.029, respectively) and the level of AM was significantly correlated to serum level of TNF-α (r = 0.417, p = 0.003) but not significantly correlated to IL-6 compared with the AGA group. In conclusion, the significant increase of AM, TNF-α and IL-6 in the idiopathic IUGR group might contribute to the uteroplacental haemodynamic alterations and can serve as a useful biochemical marker. Significant correlation between AM and TNF-α could hypothesise the existence of a complex interaction between AM and this inflammatory cytokine.

Comparative analysis of Laser and LED phototherapies pain control after insertion of elastomeric separators in orthodontics patients: Clinical trial.

The aim of this study was to evaluate the effectiveness of pain modulation following Laser or LED phototherapies during the process of tooth separation. This was a longitudinal randomized controlled clinical trial in four observational times carried out in 60 patients (15 males, 45 females, average 24.1 years old) who were randomly divided into three groups: G1 (LED, AsGaAl, λ850 ± 10 nm, 150 mW, 17 J/cm2, 57 s per session), G2 (Laser, AsGaAl, λ780 nm, 70 mW, 20.0 J/cm2, 240 s per session) and G3 (Non-irradiated Control). All patients were submitted to tooth separation using elastomeric separators. The pain level was measured by using a visual analogue scale (VAS) immediately after insertion (T1) of the elastic, at 48 (T2), 96 (T3) hours and 6 days (T4). It was observed an increase of the pain on the Control group from T1 to T2, with statistical significance. Pain levels in the LED and Laser groups were always significantly lower (<0.001), except for T1. According with the results of the present study it may be concluded that, either LED or Laser phototherapies, were effective in reducing the pain level after dental separation process when compared to the control group.

Post-treatment assessment of acute Toxoplasma infection during pregnancy.

Serological immune profile in cases of Toxoplasma infection is heterogeneous, and responses may be delayed or fail to be represented: this makes it an unreliable method for diagnosis and/or treatment follow-up. Therefore, the present study relied on a sensitive and specific molecular procedure (nested polymerase chain reaction, PCR), using the whole blood sample to establish the diagnosis of acute maternal toxoplasmosis in 27 pregnant women. All of them received the recommended dose of Spiramycin. Only 19 returned for follow-up visits and completed their pregnancies to full term. The achievement of the treatment regimen was evaluated according to the results of PCR amplification of T. gondii DNA at the end of the treatment course. Patients who continued to have positive PCR results were given another treatment course. After treatment with a single course of Spiramycin, 11(57.9%) patients retained T. gondii DNA in their peripheral blood and in eight (42.1%) patients, T. gondii DNA was absent by PCR: four (21.01%) patients received up to three courses of treatment.

Distribution of macrophages in the human fallopian tubes: an immunohistochemical and electron microscopic study.

The fallopian tubes are essential for the normal transport of gametes, fertilisation and early embryonic development and transport. Their locomotive force is mainly due to the contractility of the smooth muscle cells, as well as to the ciliary activity of the tubal epithelium. Steroid hormones such as oestradiol and progesterone mediate changes in tubal morphology, in particular the tubal epithelium. It is well known that macrophages participate in the immune system, but recent studies have shown that they also play other roles under physiological conditions. They are known to be a source of prostaglandins of the E series, which influence the contractility of the uterine tube. Lymphocytes in the tubal mucosa can be involved in the process of immune tolerance, which could enable sperms and blastocysts to be transported through the oviduct under normal conditions without the activation of local immune mechanisms. Most of the evidence for mucosal immune responses in the female reproductive tract is related to the vagina, with less information available for the uterus. The less known segment in this regard is the oviduct, which prompted us to review and summarise the current state of knowledge of the immune system at the level of the human oviduct. The present study was therefore undertaken to examine the distribution and morphological properties of macrophages in the endosalpingeal stroma and smooth muscle layer of the human fallopian tubes. Thirty fresh fallopian tubes were examined, taken at the proliferative (7 cases) and secretory (12 cases) phases of the menstrual cycle, and during the postmenopausal period (11 cases). Sections were stained by immunocytochemistry with a primary antibody (CD 68) and were used for counting the macrophages. Ultrathin sections were stained with lead citrate and uranyl acetate and studied by means of electron microscopy to asses the ultrastructure of the macrophages. A significant difference was observed between reproductive and postmenopausal women in the number of macrophages (p<0.05). This study may help to clarify the possible role of macrophages of the uterine tubes in some cases of infertility in females.

Optimal selective sentinel lymph node dissection in primary malignant melanoma.

OBJECTIVE: To determine the optimal approach of selective sentinel lymph node (SLN) dissection in primary malignant melanoma. DESIGN: Consecutive patient study. Prior to selective SLN dissection and wide local excision of the primary melanoma biopsy site, technetium Tc 99m sulfur colloid was injected intradermally around the primary melanoma or biopsy site to mark the SLN. Isosulfan blue (Lymphazurin, Hirsch Industries Inc, Richmond, Va) was injected at the primary biopsy site immediately before the surgical procedure. SETTING: Teaching hospital tertiary care referral center. MAIN OUTCOME MEASURES: Successful identification of SLNs being defined as positive for microscopic metastatic melanoma by blue dye staining, radioisotope uptake, or both. RESULTS: Selective intraoperative mapping by gamma probe and visualization of blue dye-stained SLN(s) resulted in a 98% (160/163) successful identification rate. Thirty patients (18.4%) had microscopic metastatic melanoma of the SLN(s), 22 of whom had subsequently completed lymphadenectomy. In 4 (18.2%) of these 22 patients, further microscopic metastatic disease was found in 1 of 8 nodes, 1 of 8 nodes, 1 of 28 nodes, and 1 of 9 nodes. No notable complications were encountered. Five recurrent cases from patients with SLNs without microscopic metastatic melanoma (3.8%) and 2 from patients with SLNs with microscopic metastatic melanoma (6%) were found during a median follow-up period of 463 days. A second primary melanoma developed in 2 patients; neither had no local recurrence. CONCLUSIONS: Sequential combination of preoperative lymphoscintigraphy and intraoperative mapping is a reliable way to identify regional SLN. The frequency of microscopic metastatic melanoma of the SLN(s) is 18.4%. Gamma-probe--guided resection minimizes the extent of lymph node dissection. Further follow-up is needed to assess the outcome of this group of patients for regional and systemic recurrences.

Discordancy between clinical predictions vs lymphoscintigraphic and intraoperative mapping of sentinel lymph node drainage of primary melanoma.

OBJECTIVE: To evaluate discordancy between clinical predictions and lymphatic drainage patterns of primary cutaneous melanoma as determined by preoperative lymphoscintigraphy and intraoperative lymphatic mapping of sentinel lymph nodes (SLNs). DESIGN: Before selective SLN dissection, 226 consecutive patients with melanoma underwent preoperative lymphoscintigraphy. SETTING: Teaching hospital tertiary care center. MAIN OUTCOME MEASURE: Correlation of lymphatic drainage patterns from the following 3 data sources: clinical predictions preoperatively based on anatomical location of primary melanoma, lymphatic drainage patterns as determined by preoperative lymphoscintigraphy, and identification of SLNs during surgery. RESULTS: Preoperative lymphoscintigraphy was successful in identifying at least 1 SLN in all 226 patients. In head and neck melanomas, at least 1 SLN was identified in an area outside what would have been clinically predicted in 11 (36.7%) of 30 cases. Discordancy for trunk melanomas was seen in 24 (25.3%) of 95 cases. Extremity melanomas showed drainage to unexpected SLNs in 6 (13.6%) of 44 and 3 (5.3%) of 57 patients for the upper and lower extremities, respectively. The overall rate of discordancy was 44 (19.5%) of 226. The SLNs were identified in surgery in all but 4 cases. CONCLUSIONS: Discordancy is most frequent in melanomas of the head and neck region, followed by that of the trunk. Preoperative lymphoscintigraphy identifies the occasional cases in the upper and lower extremities where drainage occurs to a basin that is not clinically predictable. Preoperative lymphoscintigraphy is a prerequisite for characterizing the lymphatic drainage pattern in patients with primary melanoma, especially for sites such as head and neck as well as trunk, before selective SLN dissection.

Resection of metastatic melanoma following wire localization guided by computed tomography or ultrasound.

Melanoma is an aggressive tumour with the propensity to metastasize through the lymphatic system and blood. Patients at high risk for developing metastatic disease are evaluated clinically together with chest X-rays and when indicated computed tomography (CT) scans. Wire localization is routinely used in non-palpable breast cancer to facilitate surgical resection. This study demonstrates the applicability of wire localization and surgical resection of non-palpable, deep subcutaneous or Intramuscular metastatic melanoma detected by CT or ultrasound. The medical records of six patients with malignant melanoma were retrospectively reviewed. Each patient with malignant melanoma developed metastatic involvement detected by CT scan or ultrasound at the UCSF/Mount Zion Medical Center, California, USA. A Copanz needle was inserted into the tumours under local anaesthesia. The patients were transported to the operating room and underwent wire-guided surgical resection of the tumour under general anaesthesia or intravenous sedation. In all six patients the tumour was successfully resected following CT- or ultrasound-guided wire localization of the metastatic foci. In conclusion, nonpalpable metastatic melanoma may be resected using CT-or ultrasound-guided wire localization. This technique offers several advantages, Including minimal surgical dissection, shorter operative times and decreased postoperative morbidity.

Role of laparoscopic cholecystectomy in the management of gangrenous cholecystitis.

BACKGROUND: Laparoscopic cholecystectomy is increasingly being employed as the initial surgical approach in patients with acute cholecystitis. Gangrenous cholecystitis will be unexpectedly encountered in a proportion of these patients. The applicability of laparoscopic techniques and its outcome in this group of patients remain poorly defined. This paper presents our experience with laparoscopic cholecystectomy in the treatment of patients with gangrenous cholecystitis. METHODS: From January 1994 to March 1999, 281 patients underwent laparoscopic cholecystectomy for acute cholecystitis. Operative and histopathologic data were obtained and the subgroup with gangrenous cholecystitis identified (53 of 281, 18.8%). Laparoscopic cholecystectomy was the initial surgical approach in 44 (83%) and was successfully completed in 30 of 44 (68%) patients. Conversion to an open cholecystectomy became necessary in 14 of 44 (32%). A retrospective review comparing these two groups of patients was performed. RESULTS: Of the 44 patients, there were 25 males and 19 females, with a mean age of 64.6 years. Mean duration of symptoms prior to presentation was 2.3 and 2.9 days in the laparoscopic and conversion groups, respectively. Clinical presentation included the presence of right upper quadrant pain (98%), leukocytosis (91%), fever (16.3%), and jaundice (9%). Liver function test abnormalities included elevations of alkaline phosphatase (25%), aspartate aminotransferase (20.4%), alanine aminotransferase (22.7%), and total bilirubin (18.1%). Ultrasonography revealed the presence of gallstones (88.6%), gallbladder wall thickening (52.3%), and pericholecystic fluid (20.5%). Air in the gallbladder wall and intraluminal membranes were present in 2 patients and 1 patient, respectively. Nuclear scans performed in 29 patients revealed cystic duct obstruction in all 29. The rim sign was present in 1 patient. A laparoscopic cholecystectomy was attempted in 44 of 53 patients and was successfully completed in 30 (68%). Conversion to an open procedure became necessary in 14 of 44 (32%). No difference in preoperative factors was noted among the two groups. The mean duration of surgery in patients undergoing a successful laparoscopic cholecystectomy was 107 minutes versus 110 minutes when conversion was necessary. There were no deaths in the study population. Morbidity occurred in 40% of the laparoscopic group and 71% of the conversion group. No patient in the laparoscopic group required admission to the intensive care unit. In contrast, 4 of 14 patients in the conversion group required a mean of 2.6 days in the intensive care unit. Postoperative hospital stay was 3.3 versus 5.5 days in the two groups, respectively. CONCLUSIONS: Preoperative factors did not predict conversion in patients undergoing laparoscopic cholecystectomy for presumed acute cholecystitis who are found to have gangrenous cholecystitis. Duration of surgery is not significantly prolonged and outcome in terms of morbidity, admission to the intensive care unit, and hospital stay are significantly better in patients in whom laparoscopic cholecystectomy is successful.

Abscess of an accessory spleen.

Accessory spleens are not infrequent and occur in 11 to 44 per cent of the population with a greater incidence in those with hematological disease. They may remain clinically silent or result in a number of pathologic processes. Abscess of an accessory spleen is rare but must be considered in the differential diagnosis of fever of unknown origin or sepsis in select groups of patients. Computerized tomography is the imaging modality of choice and may also be used in the percutaneous drainage of select cases. Laparoscopic splenectomy in the hands of the experienced laparoendoscopic surgeon is a viable treatment option.

Sentinel lymph node dissection for primary cutaneous melanoma: a community hospital's initial experience.

Management of the regional lymph nodes remains the most controversial aspect of treating patients with intermediate-thickness cutaneous melanoma. Prospective studies have failed to demonstrate a significant survival advantage for patients undergoing elective lymph node dissection. The sentinel lymph node dissection (SLND) technique has been proposed as a method of accurately identifying patients with occult metastases in whom a regional lymph node dissection would be indicated. The majority of studies evaluating this technique have come from academic centers, most with dedicated melanoma clinics. This report describes the initial experience with SLND at a community hospital. Fifteen patients with intermediate-thickness primary cutaneous melanoma underwent preoperative lymphoscintigraphy with 99Tc-sulfur colloid. In addition, intraoperative lymphatic mapping using intradermally injected isosulfan blue was performed. Dissection was guided by radioactivity levels (in counts per second) as measured by a hand-held gamma probe. The resected lymph node or nodes were evaluated for micrometastases using routine hematoxylin and eosin staining and immunohistochemistry with S-100 and HMB-45. All patients were followed clinically for any evidence of recurrence. A sentinel node(s) was identified on preoperative lymphoscintigraphy in all 15 patients (100%). A single sentinel node was identified in 11 of 15 (73%), two nodes in 3 (20%), and one node in 1 (6.7%). The hand-held gamma probe reading correlated well with the site marked the "hot spot" (600-15,320 cps for the hot spot versus 10-350 cps for background). The sentinel lymph node was successfully identified and resected in all 15 patients. Blue-stained lymphatics and/or lymph nodes were present in 8 of 15 (53%) cases. Histopathology was negative for evidence of occult micrometastases in all patients. At mean follow-up of 221 days, all 15 patients remain with no evidence of disease. The outcomes for mapping and harvesting the sentinel node at a community institution compare favorably with results at major academic institutions. SLND may therefore be offered to patients with intermediate-thickness cutaneous melanoma in the community hospital setting with regional lymph node dissection and adjuvant interferon alpha-2b as options for patients with nodal micrometastases.

Interferon alpha2b inhibits the murine melanoma cell line Cloudman S91 in vivo but not in vitro: a model for studying tumor cell-cytokine interactions.

Interferon alpha2b has recently been shown to improve outcome in patients with metastatic malignant melanoma. The high-dose interferon therapy used is however associated with significant systemic adverse effects. These adverse effects are likely related to the multitude of actions of interferon which in addition to its antineoplastic effects also possesses antiviral and immunomodulating properties. Elucidation of the mechanism of the antiproliferative effects of interferon may allow for the development of agents that possess the antineoplastic properties while being devoid of the other effects that make interferon toxic. In the animal model developed for this study tumors in mice receiving interferon alpha2b grew at a slower rate and achieved a small final tumor volume (3040 +/- 690 vs 1400 +/- 314 mm3 for the control and treated groups respectively, P < 0.05). Furthermore the final tumor weight in the treated group was significantly smaller (1.50 +/- 0.21 g vs 2.76 +/- 0.46 g for the treated and control groups respectively; P = 0.036). The (3-[4,5-Dimethylthiazol-2-y]-2,5-diphenyltetrazolium bromide) (MTT) colorimetric assay failed to reveal any direct effects of interferon alpha2b on this murine melanoma cell line. This antiproliferative effect of interferon alpha2b was in addition found to be independent of alterations in the expression of the angiogenic cytokines vascular endothelial growth factor, basic fibroblast growth factor, and transforming growth factor beta.

Carotid artery injuries and their management.

BACKGROUND: Major vascular injuries in the region of the neck are most frequently the result of penetrating trauma. Evaluation and management of patients with injury to Zone II of the neck remains highly controversial. Most studies involve small number of patients with a lack of standardization of the nature of the injury in reporting outcome. It is the purpose of this study to propose a grading scale for vascular injuries in the neck that would allow for more uniform reporting of such injuries. EXPERIMENTAL DESIGN: A retrospective review of all patients treated for penetrating trauma to the neck was performed and the subset of patients with major vascular injuries identified. Data from this group of patients are presented. SETTING: Level II urban trauma center. PATIENTS AND INTERVENTIONS: During the period July 1984 to June 1994, 107 patients were treated for penetrating neck trauma. Injuries to the major arteries of the neck were present in 18 of the 107 patients (16.8%). All injuries were graded on the developed scale. Management protocol was based on the grade of the injury. Grade 1 injuries were managed non-operatively with systemic anticoagulation and low molecular weight dextran. Grade 2 injuries were treated with primary repair. Injuries of Grades 3 and 4 were treated by primary repair or interposition graft. Exceptions were isolated injuries of the external carotid artery, which were treated by ligation alone. RESULTS: Of the 18 patients with carotid artery injuries, 2 had injuries of the external carotid artery, treated with ligation alone. The internal carotid artery was injured in 7 cases. An interposition saphenous vein/PTFE graft was used in all cases. In 9 cases the common carotid artery was injured. Repair was accomplished by a combination of either a primary repair or interposition graft. Overall mortality was 3/16 (16.6%). No new or worsening of neurologic deficit occurred in any patient. CONCLUSIONS: Carotid artery injuries occur in about 17% of patients with penetrating neck trauma. Data regarding management and prognosis in these patients are at best concflicting, in part, due to lack of a standardized classification system. The proposed grading scale is designed to overcome this problem.

Identification of bilateral breast sentinel lymph nodes draining primary melanoma of the back by preoperative lymphoscintigraphy and intraoperative mapping.

A 30-year-old white woman with a primary malignant melanoma of her right back at the Sappey line, 4 cm from the midline at the L2 level, underwent preoperative lymphoscintigraphy and intraoperative mapping of the sentinel lymph node using lymphazurin injection at the primary site and a hand-held gamma probe. Lymphoscintigraphy showed one sentinel lymph node in each breast and another one in the right axilla. These three sentinel lymph nodes were accurately identified using a hand-held gamma probe during operation. An additional sentinel and one nonsentinel lymph node from the right axilla were harvested. All four sentinel lymph nodes were blue and showed significantly elevated radioactivity compared with background. Histologic analysis showed that all these lymph nodes were negative for metastatic melanoma. She has been followed for a period of 26.7 months since her selective sentinel lymphadenectomy and has been free of disease to date. This case illustrates the importance of preoperative lymphoscintigraphy in identifying in-transit sentinel lymph nodes in both breasts in addition to the clinically predictable sentinel lymph node(s) in the right axilla.

Laparoscopic approach to the management of incarcerated hernia of appendices epiploicae: report of two cases and review of the literature.

Appendices epiploicae may be involved in several intraabdominal pathologic processes, including occasional incarceration in hernias. This diagnosis is most frequently made intraoperatively. In addition to repair of the hernia, management includes a thorough evaluation of the involved appendage in terms of its viability. Any appendage found to be nonviable or of doubtful viability needs to be excised. Such evaluation and excision has traditionally required an open approach. Laparoscopy offers the advantage of a comparable evaluation of viability, the ability to excise the affected appendage if necessary, and a significantly lower morbidity. The requirement of general anesthesia and the need to generate a pneumoperitoneum may be limiting factors in patient selection.

Lymph node micrometastases from breast carcinoma: reviewing the dilemma.

BACKGROUND: The presence or absence of regional lymph node metastases has been one of the most important determining factors in recommending adjuvant chemotherapy for patients with breast carcinoma. However, because of the 15-20% failure rate at 5 years for lymph node negative patients, other tumor-related prognostic factors have gained greater significance in this decision-making process. Many investigators have reported finding micrometastases that were not detected by routine sectioning of the lymph nodes but were identified by multiple sectioning and additional staining. This review attempts to evaluate the role of occult lymph node micrometastases and their relevance to disease recurrence. METHODS: A literature search of the entire MEDLINE data base was conducted. All relevant articles were reviewed for the criteria they used to define micrometastases. The frequency of detection of micrometastases by various methodologies and the prognostic significance of such deposits were examined. RESULTS: Tumor deposits involving the lymph nodes were found to be arbitrarily categorized as either micrometastases or macrometastases, with the cutoff point ranging from 0.2-2.0 mm. The detection rate of such deposits by conventional techniques was inadequate. Serial sectioning and immunohistochemistry appeared to increase the detection rate by 9-33%. A definite survival disadvantage was noted for patients with such occult metastases. CONCLUSIONS: Current routine histologic examination of regional lymph nodes underestimates breast carcinoma metastases. Serial sectioning and immunohistochemistry increase the yield but are too labor-intensive and expensive for routine use. However, the introduction of the sentinel lymph node biopsy in lieu of axillary lymph node dissection in cases of breast carcinoma holds promise for making these methods practical and cost-effective.

Recombinant human granulocyte macrophage-colony stimulating factor (rhGM-CSF) and autologous melanoma vaccine mediate tumor regression in patients with metastatic melanoma.

In mice, significant immunoprotection was achieved using B16 melanoma cells transfected with granulocyte-macrophage colony-stimulating factor (GM-CSF) as vaccines (Dranoff G, Jaffee E, Lazenby A, et al. Vaccination with irradiated tumor cells engineered to secrete murine granulocyte-macrophage colony-stimulating factor stimulates potent, specific, and long-lasting anti-tumor immunity. Proc Natl Acad Sci USA 1993;90:3539-43). The aim of this study is to test the hypothesis that recombinant human GM-CSF (rhGM-CSF) injected with autologous melanoma vaccine may result in tumor rejection in melanoma patients. Twenty stage IV melanoma patients were treated as outpatients with multiple cycles of autologous melanoma vaccine and bacillus Calmette-Guérin (BCG) plus rhGM-CSF injection in the vaccine sites. Two patients (10%) showed a complete response, with one patient showing resolution of subcutaneous, hepatic, and splenic metastases. In the second patient, buccal, subcutaneous, pulmonary, paraaortic, hepatic, splenic, and retroperitoneal metastases regressed completely. Two patients (10%) showed partial response, with regression of a paraaortic metastasis in one patient. In the second patient, there was shrinkage (> 75%) of a large hepatic lesion. One patient has been rendered free of disease after resection of a single pulmonary metastatic nodule. Three patients (15%) had stable disease during treatment but subsequently developed progression of disease. In 12 patients (60%), the disease progressed. Side effects were minimal. In a separate pilot study, 15 stage IV melanoma patients were also treated with autologous melanoma vaccine with BCG but not with rhGM-CSF; none responded. The fact that four patients showed objective responses to active specific immunotherapy with rhGM-CSF demonstrates that melanoma patients bearing a significant tumor burden may respond specifically to their autologous melanoma.