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PubMed1984

Adjuvant chemotherapy with fluorouracil, doxorubicin, and cyclophosphamide, with or without Bacillus Calmette-Guerin and with or without irradiation in operable breast cancer. A prospective randomized trial.

Between May 1977 and April 1980, 238 patients with operable breast cancer were treated with adjuvant fluorouracil, doxorubicin, and cyclophosphamide (FAC) chemotherapy. All patients were randomized to receive FAC alone or FAC with nonspecific immunotherapy with Bacillus Calmette-Guerin (BCG) vaccine. A randomization for routine postoperative irradiation was included in the study in May 1978. At the median follow-up of 33 months, 53 patients had developed recurrent disease. Up to the present time, there have been no significant differences in the disease-free survival of patients treated with FAC alone from those treated with FAC + BCG (P = 0.21). The disease-free survival for patients treated with and without routine postoperative irradiation was similar (P = 0.99). Disease-free survival of premenopausal and postmenopausal women was similar. The overall estimate of disease-free survival was 72% at 3 years.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1984

Adriamycin, dibromodulcitol, and mitomycin combination chemotherapy for patients with metastatic breast carcinoma previously treated with cyclophosphamide, methotrexate, 5-fluorouracil, vincristine, and prednisone.

Twenty-six evaluable patients with metastatic breast carcinoma previously treated with a combination of cyclophosphamide, methotrexate, 5-fluorouracil, vincristine, and prednisone (CMFVP) were treated with a combination of doxorubicin (Adriamycin), dibromodulcitol, and mitomycin (ADM). Four patients (15%) achieved complete remission, and 10 patients (39%) had a partial response. Five patients (19%) had stable disease, and seven patients (27%) experienced disease progression. The median time to disease progression was 10 months for responding patients (range, 4-44 months) and 5 months (range, 2-13 months) for patients with stable disease. The median survival duration was 15 months (range, 6-44+ months) for responders, 11 months (range, 2-27 months) for patients with stable disease, and 4 months (range, 2-41 months) for nonresponders. Two of the four patients with complete remission are alive and in continued remission at a follow-up of 44 and 40 months. Seventy-one patients with greater than or equal to two sites of metastasis responded, whereas 23% of patients with greater than or equal to three metastatic sites responded. Although higher responses were seen with soft tissue and osseous metastasis, responses were observed in all three sites of metastasis. This combination chemotherapy regimen with ADM is an effective second-line program for patients who have previously received CMFVP chemotherapy.

Adult↗
PubMed1985

A comparative randomized trial of vinca alkaloids in patients with metastatic breast carcinoma.

The therapeutic efficacy of vincristine, vinblastine, and vindesine were evaluated in a prospective randomized trial in patients with metastatic breast carcinoma. All patients were refractory to doxorubicin-containing chemotherapy. Vincristine was administered at 0.4 mg/m2/1/day by continuous infusion (CI), vinblastine at 1.7 mg/M2/1/day by CI, and vindesine at 1.2 mg/M2/1/day by CI or intermittent bolus (IB) over 5 days. The courses were administered at 2-week intervals for vincristine and 3-week intervals for vinblastine and vindesine. Ninety-nine patients were evaluable for response. The 15 patients treated with vincristine had no objective response. Of 23 patients treated with vinblastine, there were 2 complete responses (9%) and 5 partial responses (22%). Of 31 patients treated with CI vindesine, there were 6 partial responses (19%). Of 30 patients treated with IB vindesine, there were 5 partial responses (17%). The median duration of disease control was 13 weeks (range, 8-140+) for vinblastine, 18 weeks (range, 8-34) for CI vindesine, and 20 weeks (range, 12-47) for IB vindesine. These data illustrate that vinblastine (CI) and vindesine (CI or IB) have significant antitumor activity in patients with refractory metastatic breast carcinoma and that vincristine has not antitumor activity in similar patients.

Adult↗
PubMed1985

Five-day continuous-infusion vinblastine in the treatment of breast cancer.

One hundred six evaluable patients with metastatic breast cancer refractory to prior chemotherapy were treated with 5-day intravenous infusions of vinblastine at 1.4 to 2.0 mg/m2/day, through silastic elastomer permanent central venous catheters. Thirty-nine patients achieved objective responses; 5 were considered complete. The overall response rate of 37% was independent of prior exposure to intermittent intravenous vinca alkaloids or prior response to front-line doxorubicin combination chemotherapy. Objective responses were documented in 48% of the patients who received daily doses above 1.7 mg/m2 and in 32% and 29% of those treated with 1.7 mg/m2 or less, respectively (P = 0.10). Myelosuppression was more severe in responders, who received higher average doses, (median average nadir, 850 granulocytes/mm3) than in nonresponders (median, 1300 granulocytes/mm3), but was always rapidly reversible. Infections related to neutropenia were uncommon. Catheter-related toxicities occurred in 13 of 106 patients. Other toxicities were limited. These results confirm that vinblastine given as a continuous 5-day infusion is one of the most effective agents in the treatment of metastatic breast cancer and suggest that its activity is dose-dependent.

Adult↗
PubMed1985

A totally implanted venous access system for the delivery of chemotherapy.

The use of an Ommaya Capsule-Catheter System for the delivery of chemotherapy in cancer patients with inadequate peripheral veins has been studied over a 6-year period. Between 1978 and 1984, 76 Ommaya capsules were implanted in 68 patients, providing a collective experience of over 28,000 venous access days. Two patients were lost to follow-up. The results of the capsule-catheter system performance indicates a functional rate of over 90%. The complications included a 6.7% catheter occlusion rate, and a 2.7% capsule leakage rate. This accounts for an overall catheter related complication rate of 9.4%.

Antineoplastic Agents↗
PubMed1985

A comparative study of PALA, PALA plus 5-FU, and 5-FU in advanced breast cancer.

Sixty-three patients with Stage IV breast carcinoma refractory to standard combination chemotherapy agents such as 5-fluorouracil (5-FU) were entered into a study to determine the efficacy of a multiple dose schedule of N-(phosphonacetyl)-L-aspartic acid (PALA) and whether the addition of PALA improves the therapeutic efficacy of 5-FU. Patients were randomized to receive either PALA, 800 to 1000 mg/m2 per day for 5 days every 2 weeks; or PALA + 5-FU, 400 mg/m2 per day for 5 days, and 300 mg/m2 per day for 5 days every 28 days, respectively. The PALA alone arm of the study was closed after 20 patients had been treated and was replaced by 5-FU, 300 to 400 mg/m2 per day for 5 days every 21 days. Overall response rates were 5% for PALA alone, 28% for PALA + 5-FU, and 14% for 5-FU alone. All patients who responded to PALA + 5-FU or 5-FU alone had received prior therapy in which 5-FU was part of the combination chemotherapy program and were considered refractory to this drug. Toxicity affected the gastrointestinal tract but was tolerable in all three arms of the study. Myelosuppression was negligible for PALA and PALA + 5-FU and moderate for 5-FU. The authors concluded that PALA + 5-FU was superior to PALA alone in the therapy of these heavily pretreated patients. PALA alone had marginal efficacy. In view of its low hematologic toxicity, PALA + 5-FU may be combined with more myelosuppressive drugs. Additional studies are necessary to ascertain whether PALA + 5-FU is therapeutically superior to a full-dose schedule of 5-FU.

Adult↗
PubMed1987

Mitoxantrone, cyclophosphamide, and fluorouracil in metastatic breast cancer unresponsive to hormonal therapy.

Fifty-two patients with hormonally unresponsive or estrogen receptor negative metastatic breast cancer who had not received prior chemotherapy received mitoxantrone 10 mg/m2, cyclophosphamide 500 mg/m2, and 5-fluorouracil 1000 mg/m2 (MCF) by short intravenous infusion every 21 days. Disease that was resistant or stable to this regimen was treated with doxorubicin 25 mg/m2/day for two days and vinblastine 1.4 mg/m2/day for four days (DV). Both drugs were given by continuous infusion. Thirty-one partial remissions and four complete remissions occurred after treatment with MCF. Only thirty-four evaluable patients crossed to the DV phase with partial remission (11 patients), stable (five patients), or resistant (18 patients) disease. Eleven patients' responses were upgraded. The median overall time to progression (TTP), defined as the sum of the TTP on MCF and TTP on DV, was 12 months. The median survival of all patients was 19 months. Granulocytopenia was the dose limiting toxicity for MCF, but cumulative thrombocytopenia was noted. Nausea and vomiting occurred in most patients but was mild. Severe alopecia occurred in half the patients. One patient developed congestive heart failure after receiving a cumulative dose of 206 mg/m2 of mitoxantrone. The incidence of infectious complications was 35% on each regimen; 50% of these were mild. MCF is an effective combination that was well tolerated. Objective responses, durations of response, and survival were similar, but not superior, to standard doxorubicin-based combinations. Toxicity was somewhat less.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1987

Chemotherapy with mitoxantrone in combination with continuous infusion vinblastine for metastatic breast cancer.

The efficacy of mitoxantrone in combination with vinblastine was assessed in 156 patients with metastatic breast cancer who had been treated previously with one or multiple chemotherapeutic regimens. Mitoxantrone was given by random assignment, either as a 10 mg/m2 single intravenous dose or in five consecutive daily fractions of 2 mg¿2. Vinblastine was given as a continuous intravenous infusion of 1.2 mg/m2 daily for 5 days. In 115 evaluable patients previously treated with doxorubicin, 21 objective responses (18%) and 11 minor responses (10%) were observed with similar distribution in the two treatment groups. Median time to progression was 27 weeks and 23 weeks, respectively. Eight (32%) of 25 patients who had not received doxorubicin achieved objective remissions and two (8%) had minor responses. Toxic effects were similar for the two treatment schedules. Major toxicities were myelosuppression and neutropenic fever. Other toxicities were mild. Cardiotoxicity, presumably caused by mitoxantrone, occurred in four patients. The combination of mitoxantrone and vinblastine appeared to offer no advantage over single-agent therapy, probably because of the dosage reduction required by the overlapping myelosuppressive toxicity.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1990

Childhood primary hepatocellular carcinoma and hepatitis B virus infection.

In the 7-year period between 1980 and 1987, six cases of childhood primary hepatocellular carcinoma (PHC) were confirmed histologically in our institution. Hepatitis B surface antigen (HBsAg) seropositivity was confirmed in five of the cases, and tissue HBsAg was shown in four of these using the Shikata's orcein stain. An associated maternal HBsAg seropositivity was shown in two of the seropositive children. The youngest seropositive patient who developed PHC was 7 years old. The mother of this patient was also seropositive. These observations support a causal relation between childhood Hepatitis B virus infection and PHC. The importance of vertical or perinatal transmission of HBV in the causation of childhood PHC and the prophylactic role of childhood vaccination is emphasized. Attention is also drawn to the relative short malignant transformation time seen in some of these patients.

Carcinoma, Hepatocellular↗
PubMed1991

Use of intravenous immunoglobulin in acquired immune deficiency syndrome.

Patients infected with the human immunodeficiency virus (HIV) may have an antibody deficiency and a deficiency of cellular immunity. Intravenous immunoglobulin (IVIG) preparations may benefit HIV-infected children and adults with recurrent bacterial infections at doses of 200 to 400 mg/kg every 2 to 4 weeks. In addition, IVIG (1 to 2 g/kg) is effective at raising platelet counts to hemostatic levels in HIV-infected patients with idiopathic thrombocytopenic purpura and life-threatening bleeding. Indirect evidence also suggests that IVIG may be effective in preventing Pneumocystis carinii pneumonia. Finally, recent studies suggest that specific anti-HIV antibody preparations may have a therapeutic role, either as immunoglobulin concentrates or as immunoadhesions and immunotoxins. However, further investigations are needed to exclude antibody enhancement of HIV infection by the Fc receptor or the complement receptor.

Acquired Immunodeficiency Syndrome↗
PubMed2001

Microtubule integrity is essential for apical polarization and epithelial morphogenesis in the thyroid.

In this study, we examined the contribution of microtubules to epithelial morphogenesis in primary thyroid cell cultures. Thyroid follicles consist of a single layer of polarized epithelial cells surrounding a closed compartment, the follicular lumen. Freshly isolated porcine thyroid cells aggregate and reorganize to form follicles when grown in primary cultures. Follicular reorganization is principally a morphogenetic process that entails the assembly of biochemically distinct apical and basolateral membrane domains, delimited by tight junctions. The establishment of cell surface polarity during folliculogenesis coincided with the polarized redistribution of microtubules, predominantly in the developing apical poles of cells. Disruption of microtubule integrity using either colchicine or nocodazole caused loss of defined apical membrane domains, tight junctions and follicular lumina. Apical membrane and tight junction markers became randomly distributed at the outer surfaces of aggregates. In contrast, the basolateral surface markers, E-cadherin and Na(+),K(+)-ATPase, remained correctly localized at sites of cell-cell contact and at the free surfaces of cell aggregates. These findings demonstrate that microtubules play a necessary role in thyroid epithelial morphogenesis. Specifically, microtubules are essential to preserve the correct localization of apical membrane components within enclosed cellular aggregates, a situation that is also likely to pertain where lumina must be formed from solid aggregates of epithelial precursors.

Actins↗
PubMed2000

Influence of water exposure on three-body wear of composite restoratives.

The objective of this investigation was to study the influence of water exposure on the three-body wear of composite restoratives. A three-body wear instrumentation was used to investigate the wear resistance of five composite restoratives [Silux Plus (SX), Z100 (ZO), Ariston pHc (AR), Surefil (SF) and Tetric Ceram (TC)] with and without exposure to water. An amalgam alloy [Dispersalloy (DA)] was used as control. Ten specimens were made for each material. The specimens were conditioned in artificial saliva at 37 degrees C for 24 h and randomly divided into two groups of 5. The first group was subjected to wear testing immediately after the 24 h conditioning period, while the second group was conditioned in distilled water at 37 degrees C for 7 days prior to wear testing. All materials were wear tested at 15 N contact force against SS304 counter-bodies for 20,000 cycles with millet seed slurry as third-body. Wear depth (microm) was measured using profilometry, and results were analyzed by ANOVA/Scheffe's and independent sample t-tests at significance level 0.05. Ranking of wear resistance was as follows: without water exposure: DA > ZO > SF > AR > SX > TC; with water exposure: DA > ZO > SX > SF > AR > TC. Wear factor ranged from 2.20 for ZO to 7.13 for TC without water exposure and from 46.00 for ZO to 143.00 for TC with exposure to water. Exposure to water significantly increased three-body wear for all composite restoratives, but did not affect wear of the amalgam alloy. The effects of water exposure must be considered for the evaluation of wear in all polymeric composite restoratives.

Composite Resins↗
PubMed2004

Pre and post operative medical therapy for endometriosis surgery.

BACKGROUND: Endometriosis is a common gynaecological condition which affects approximately 10% of women of reproductive age (Askenazi 1997). There is a range of symptoms and most commonly women present with dysmenorrhoea, pelvic pain, infertility or a pelvic mass. Direct visualisation and biopsy during laparoscopy or laparotomy is the gold standard diagnostic test for this condition and enables the gynaecologist to identify the location, extent and severity of the disease. Surgical therapy can be performed concurrently with diagnostic surgery and may include removal (excision) or destruction (ablation) of endometriotic tissue, division of adhesions and removal of endometriotic cysts. Laparoscopic excision or ablation of endometriosis has been shown to be effective in the management of pain in mild-moderate endometriosis. Adjunctive medical treatment pre or post-operatively may prolong the symptom-free interval. OBJECTIVES: To determine the effectiveness of systemic medical therapies used for hormonal suppression before or after surgery for endometriosis, or before and after surgery for endometriosis in the eradication of endometriosis, improvement of symptoms, pregnancy rates and overall tolerability by comparing them with no treatment or placebo. SEARCH STRATEGY: We searched the Cochrane Menstrual Disorders and Subfertility group trials register (searched 10 September 2003), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 3 2003), MEDLINE (January 1966 to September 2003), EMBASE (January 1985 to September 2003) and reference lists of articles. We also contacted researchers in the field. SELECTION CRITERIA: Trials were included if they were randomised controlled trials of the use of systemic medical therapies for hormonal suppression before or after, or before and after surgery for endometriosis. DATA COLLECTION AND ANALYSIS: Data extraction and quality assessment was performed independently by using relative risk or weighted mean difference and 95% confidence intervals. MAIN RESULTS: Eleven trials were included in the review. One study comparing pre-surgical medical therapy with surgery alone showed a significant improvement in AFS scores in the medical therapy group (WMD -9.60, 95% CI -11.42 to -7.78) but this may or may not be associated with better outcomes for the patients. Post surgical hormonal suppression of endometriosis compared to surgery alone (either no medical therapy or placebo) showed no benefit for the outcomes of pain or pregnancy rates but a significant improvement in disease recurrence (AFS scores (WMD -2.30, 95% CI -4.02 to -0.58)). There were no trials identified in the search that compared hormonal suppression of endometriosis before and after surgery with surgery alone. There is no significant difference between pre surgery hormonal suppression and post surgery hormonal suppression for the outcome of pain in the one trial identified (RR 1.01, 95% CI 0.49 to 2.07). Information concerning AFS scores and ease of surgery was reported only as a descriptive summary so any difference between the groups can not be quantified from the information in the report of this trial. REVIEWERS' CONCLUSIONS: There is insufficient evidence from the studies identified to conclude that hormonal suppression in association with surgery for endometriosis is associated with a significant benefit with regard to any of the outcomes identified. There may be a benefit of improvement in AFS scores with the pre-surgical use of medical therapy. The possible benefit should be weighed in the context of the adverse effects and costs of these therapies.

Chemotherapy, Adjuvant↗
PubMed2001

Reactivity of calix-tetrapyrrole SmII and SmIII complexes with acetylene: isolation of an "N-confused" calix-tetrapyrrole ring.

The nature of the substituents present on the calix-tetrapyrrole tetra-anion ligand [[R2C(C4H2N)]4]4- (R = [-(CH2)5-]0.5, Et) determines the type of reactivity of the corresponding SmII compounds with acetylene. With R = [-(CH2)5-]0.5, dehydrogenation occurred to yield the nearly colorless dinuclear diacetylide complex [[[[-(CH2)5-]4-calix-tetrapyrrole]SmIII]2(mu-C2Li4)].THF as the only detectable reaction product. Conversely, with R = Et, acetylene coupling in addition to dehydrogenation resulted in the formation of a dimeric butatrienediyl enolate derivative [[(Et8-calix-tetrapyrrole)SmIII[Li[Li(thf)]2(mu-OCH=CH2)]]2(mu,eta2,eta'2-HC=C=C=CH)]. Reaction of the trivalent hydride [(Et8-calix-tetrapyrrole)(thf)SmIII[(mu-H)[Li(thf)]]2 or of the terminally bonded methyl derivative [(Et8-calix-tetrapyrrole)(CH3)SmIII[[Li(thf)]2[Li(thf)2](mu3-Cl)]] with acetylene resulted in a mixture of the carbide [[(Et8-calix-tetrapyrrole)SmIII]2(mu-C2Li4)].Et2O with the dimerization product [[(Et8-calix-tetrapyrrole)SmIII[Li[Li(thf)]2(mu3-OCH=CH2)]]2-mu,eta2,eta'2-HC=C=C=CH)]. The same reaction also yielded a third product, a trivalent complex [[(Et8-calix-tetrapyrrole)SmIII[Li(thf)2]]2], in which the macrocycle was isomerized by shifting the ring attachment of one of the four pyrrole rings.

Journal Article↗
PubMed2000

Field amplified stacking injection--capillary electrophoresis for quantitative analysis of released methacrylic acid from dental composites.

Field-amplified stacking injection-capillary electrophoresis (FASI-CE) applied for the first time to the study of dental materials is demonstrated in this report. CE was used to separate methacrylic acid from the other degraded components. Due to the background electrolyte being weakly basic and methacrylic acid being negatively charged, in-capillary enrichment of the analyte was achieved by FASI. A detection limit of less than 50 ppb was obtained with good reproducibility (relative standard deviation < 3%). The method was applied to the analysis of four commercially available dental composites. Results showed that FASI-CE was effective in monitoring the fabrication process and product quality of restorative materials fabricated from methacrylate-based composites by analyzing the amount of methacrylic acid released from the residual methacrylate monomers.

Composite Resins↗