Immunity during monochemotherapy with mitoxantrone: preliminary results.
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Adjuvants, Immunologic↗
Biomedical subjects
G Cartei
Publications and source records attributed to G Cartei.
A phase II study of mitoxantrone.
Thirty pretreated patients with progressive and measurable solid tumors (24/30 patients) or myeloproliferative diseases (6/30 patients) were given mitoxantrone at the dose of 5 mg/m2/day in 250 ml normal saline over 30 minutes infusion for 3 consecutive days every 3 weeks. A total of 104 cycles were administered, median 3 for each patient. 39/104 cycles were delayed for a median of 9 days (from 2 to 59 days) because of myelodepression grade I to III (median I); no infection or bleeding was observed. Grade I to II alopecia was recorded in 16 patients. Chronic cardiac toxicity was observed in one patient previously treated with adriamycin. Mitoxantrone at the studied dose schedule in heavily pretreated subjects was well tolerated every 3 to 4 weeks. In 25/30 patients evaluable for response, one patient had a PR, another had 25% reduction (both patients previously treated) and eleven patients obtained disease stability. This effectiveness, 1 PR, 1 MR, 11 disease stability, is not negligible when it is considered that mitoxantrone was the seventh median line of therapy and the fifth median antiblastic drug.
Adult↗
Phase-III clinical trial of adjuvant FAM2 (5-FU, adriamycin and mitomycin C) vs control in resectable gastric cancer: a study of the EORTC Gastrointestinal Tract Cancer Cooperative Group.
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Adenocarcinoma↗
Phase III randomized study of fluorouracil, epirubicin, and cyclophosphamide v fluorouracil, doxorubicin, and cyclophosphamide in advanced breast cancer: an Italian multicentre trial.
From February 1983 to January 1985, 497 patients with advanced breast cancer were randomly allocated to receive either epirubicin or doxorubicin in the following combination chemotherapy regimen: fluorouracil (5-FU) 500 mg/m2 intravenous (IV) on days 1 and 8; epirubicin or doxorubicin 50 mg/m2 IV on day 1; cyclophosphamide 500 mg/m2 IV on day 1 (FEC or FAC). Cycles were repeated every 21 days until progression or to cumulative doses of 700 mg/m2 for epirubicin and 550 mg/m2 for doxorubicin. Dose reductions were applied according to the standard criteria. Activity was evaluated in 443 patients (222 in the FEC arm and 221 in the FAC arm). The two experimental groups were comparable in age, performance status, menopausal status, histology, previous treatments, and site of the disease. The overall response rate (complete response and partial response [CR + PR]) was not significantly different: 53.6% for FEC and 56.5% for FAC. The median time to progression was 273 days for FEC and 314 days for FAC; the median survival time was 591 and 613 days, respectively. Leukopenia, anemia, nausea, and vomiting were significantly lower in patients treated with FEC. As for cardiotoxicity, four cases of congestive heart failure (CHF) were recorded among patients treated with FAC while only one was observed in the FEC group. These results indicate that epirubicin in a combination chemotherapy regimen is as active as doxorubicin and is significantly less toxic.
Adult↗
Phase II study of cisplatin, 5-FU, and allopurinol in advanced esophageal cancer.
Forty patients with advanced squamous cell carcinoma of the esophagus were treated with a combination of cisplatin, 5-FU (by continuous 5-day infusion), and allopurinol; 37 are evaluable for response. Thirteen remissions (35%) were obtained, including three complete and ten partial, with a median duration of 9 months. After chemotherapy, seven responding patients underwent a surgical procedure, which was radical in four. The most frequent side effects were nausea and vomiting. This regimen is effective and can be included in a multimodality approach.
Adult↗
[Cyclophosphamide, adriamycin and platinum (CAP) in the preoperative neoadjuvant phase and the therapy phase].
Forty-two patients with metastasized, and 7 patients with locally advanced forms of carcinoma of the breast were treated with a combination of three drugs: CTX 200-400 mg/sq.m. on days 1, 3 and 5, ADM 40 mg/sq.m. on day 1, and DDP 30 mg/sq.m. on days 1, 3 and 5 (CAP), every 21 days. The 42 patients with metastasized carcinoma had already received substantial pre-treatment by surgery and with adjuvant polychemotherapy +/- chemotherapy on recurrence +/- hormonotherapy +/- radiotherapy. The disease sites were: bone (30%), skin (19%), lymph nodes (13.5%), pleura (12.5%), lung (12%) and liver (11%). The 7 patients with locally advanced carcinoma had not been pre-treated; they received the same chemotherapy in the pre-operative neo-adjuvant phase. Positive responses to CAP in the cases with metastasized carcinoma according to individual disease sites (37 pre-treated patients assessable after at least two courses of therapy) were as follows in percentage terms: 24% bone lesions, 56% skin lesions, 77% lymph node lesions, 30% liver lesions, 56% lung lesions, 22% pleural lesions. 3/37 patients (8%) showed complete remission in all disease sites, while 6/37 showed partial remission. This percentage (8 + 16 = 24%) is encouraging, as CAP, in these patients, represents on average the 3rd to 4th line of therapy. Responses to neo-adjuvant CAP therapy (7 patients assessable after at least two courses of therapy) were as follows: 5 patients showed partial remission after 3-6 courses, 1 complete remission, and 1 objective improvement.(ABSTRACT TRUNCATED AT 250 WORDS)
Antineoplastic Combined Chemotherapy Protocols↗
Phase II evaluation of 4'epi-doxorubicin in patients with metastatic colorectal carcinoma.
Thirty-four evaluable patients with metastatic colorectal carcinoma (13 rectal primary and 21 colonic primary, 4 pretreated and 30 untreated) received 4'epi-doxorubicin at the dose of 75 mg/m2 i.v. once every 21 days, for a minimum of 2 courses. Symptomatic toxicity (mainly confined to gastrointestinal complaints) was short-lived and easily managed. Hematologic toxicity was mild. Transient electrocardiographic abnormalities were found in 50% of patients, without signs of significant cumulative cardiotoxicity. Three previously untreated patients achieved a partial response (lasting 16, 12 and 12 weeks, respectively) with a response rate of 9% (3%-23%, 95% confidence interval). More interestingly, all responsive patients had rectal cancer: further studies of 4'epi-doxorubicin confined to the rectal localization seem warranted.
Adult↗
FAM2 regimen in disseminated gastric cancer.
Forty-four previously untreated patients with advanced inoperable and/or disseminated gastric carcinoma were given an i.v. combination (FAM2) chemotherapy of 5-fluorouracil, 400 mg/m2 on days 1, 2 and 3, and 21, 22 and 23; adriamycin, 40 mg/m2 on days 2 and 22; and mitomycin C, 10 mg/m2 on day 1, with a recycle on day 42 (1 cycle = 41 days). Forty patients have completed 2 cycles and are evaluable (median number of cycles 5; range 3 to 8): 26 of these achieved a partial remission, with a response rate of 65%; 4 (10%) gained a stable situation for 3 to 6 months, and 10 (25%) showed progression of disease. Median duration of partial remissions was 10 months, and median survival was 15 months for responders and 5 months for nonresponders. A fall in WBC (less than 2500/microliter) occurred in 7% and of platelets (less than 80,000/microliter) in 4.5%. Total alopecia occurred in 20 of 40 patients and nausea and or weakness were common findings. No drug-related infection, bleeding or death was observed. Patients with advanced gastric carcinoma can derive useful palliation from FAM2 chemotherapy.
Adult↗
Cisplatin, bleomycin and methotrexate in the treatment of advanced oesophageal cancer.
From February 1981 to September 1982, 34 patients with metastatic or locally advanced (inoperable) epidermoid carcinoma of the oesophagus were treated with a combination of cisplatin, bleomycin and methotrexate. Thirty-one patients are now evaluable for response: 16 of 31 (52%) experienced some improvement, but only eight (26%) obtained major responses (one complete and seven partial). Responses were obtained rapidly within the first two courses. The median duration of responses was 5 months. The median survival from start of therapy was 8 months for responsive and 5 months for non-responsive patients. Gastrointestinal toxicity (cisplatin-related) and mild myelosuppression were the most prominent side-effects. This combination chemotherapy proved to be only of small efficacy in the long-term control of advanced oesophageal cancer. However, because the responses were obtained rapidly, it is conceivable that a similar regimen (with increased dosage of cisplatin) applied before surgery to patients with limited disease could obtain a reduction of the bulky tumour, with a possible increase of the resectability rate and destruction of micrometastases.
Adult↗
Chemotherapy of invasive or metastatic thymoma: report of 11 cases.
Eleven patients with invasive thymoma (seven males and four females) were seen from 1977 to 1983. All patients were adults with a median age of 46 years (range, 24-62), and presented after surgical exploration with nonremovable primary and with one or more of the following patterns of tumor extension: supraclavicular lymphadenopathy (four patients), superior vena cava syndrome (two), pleural effusion (nine), and pericardial effusion (three). The following distant metastases were also observed: lung (six patients), liver (one), skin (two), peritoneum (two), bone (one), and brain (one). The chemotherapy was administered in 4-day courses. All patients received the following: 50 mg/m2 of cisplatin iv and 40 mg/m2 of doxorubicin iv on Day 1, 0.6 mg/m2 of vincristine iv on Day 3, and 700 mg/m2 of cyclophosphamide iv on Day 4. The course was repeated every 3 weeks. Toxic effects were tolerable, as expected for the drug combination adopted. Four of 11 patients achieved objective complete regression of disease and six of 11 had partial remission, for an overall response rate of 91%; one patient had stable disease for 7 months. Six patients have died and the median survival has been 12.5 months, ranging from 5 to 23 months.
Adult↗
The evaluation of fibrinogen behavior in Hodgkin's disease: correlation with clinical stage.
Forty-four patients (9 stage II, 15 sage III, 7 stage IV, and 13 in complete remission) with Hodgkin's disease without any clinical coagulation disorder were studied. Fibrinogen behavior was evaluated by measuring fibrinogen level and using 1251-fibrinogen, the half-life, survival and fibrinogen turnover. Platelet count and fibrinogen/fibrin degradation products (FDP) were also assayed. The fibrinogen half-life, survival and turnover were significantly longer and faster, than those found in 10 healthy subjects, in stage II, III and IV subjects (p less than 0.001, p less than 0.001, p less than 0.05 for stage II; p less than 0.001, p less than 0.001, p less than 0.001 for stage III; p less than 0.005, p less than 0.005, p less than 0.001 for stage IV, respectively). In most cases, FDP values were within the normal range, although they were significantly higher than those of control group in stages III and IV. Intravascular coagulation and fibrinolysis were not found in the 13 patients with complete remission. In these patients, the behavior of fibrinogen was normal, suggesting that the parameters studied are related to the presence of the tumor, and can be useful in monitoring the state of remission.
Adult↗
Treatment of multiple myeloma with M-2 protocol and without maintenance therapy.
From September 1975 to December 1981, 63 consecutive untreated patients with multiple myeloma received the Lee M-2 protocol. We used the same drugs (melphalan, cyclophosphamide, vincristine, BCNU and prednisone) but employed the lowest suggested doses and recycled earlier, i.e. after 21-28 days. Thirty-five patients (62.5%) were in stage III, 16 (28.6%) in stage II and 5 (8.9%) in stage I. An objective response (reduction in paraprotein production rate greater than 50%) was obtained in 44 out of 56 cases (78%); 32 (57%) had a reduction greater than 75%. The median duration of response was 21.5 months. In responding patients the treatment was stopped after 1 yr and resumed only at relapse. Twenty-two out of 25 retreated patients are now evaluable. Eighteen of them (82%) responded again; in retreatment the degree of response was lower, but the duration of second response was only slightly lower than the first response (15.7 vs 21.5 months, NS). Of 7 patients receiving a third M-2 reinduction 4 responded again. The median survival for all the patients is 51 months. The high rate of second response to the M-2 regimen after an unmaintained remission brings into question the value of continuous therapy in responsive multiple myeloma.
Adult↗
Vindesine in the treatment of squamous cell carcinoma (WHO I), adenocarcinoma (WHO III), and large cell carcinoma (WHO IV) of the lung.
The antineoplastic activity of vindesine was evaluated in 57 patients with non-small-cell carcinoma of the lung, 53 patients were fully evaluable for response and toxicity. Twenty-seven patients had squamous cell carcinoma (WHO I), 14 had adenocarcinoma (WHO III), and 12 had large cell carcinoma (WHO IV). Forty percent of patients were previously treated. Vindesine was administered at a weekly i.v. dose of 3 mg/m2. Partial remissions were observed in 2 of 12 patients with large cell carcinoma and in 1 of 27 patients with squamous cell carcinoma. Among 14 patients with adenocarcinoma, 3 minor responses were observed. Drug-related toxic effects (mainly leukopenia with manageable and reversible neurotoxicity) required modification of dose in 41% of patients: this finding and previous treatment may have adversely affected the response rate. It is concluded that vindesine as a single agent has some activity in large cell carcinoma. Activity in the other histologic types was minimal but not totally absent and deserves further evaluation, possibly in non-pretreated patients.
Adenocarcinoma↗
Behavior of antithrombin III, determined as protein concentration and biologic activity, in subjects with neoplastic disease.
Antithrombin III (AT III), the primary inhibitor of plasma protease coagulation proteins, was evaluated in groups of patients with different neoplastic disease. When compared with that of 25 health subjects, the mean value of AT III biologic activity was elevated in all groups, significantly in gastrointestinal (p less than 0.02) and lung (p less than 0.001) tumors, lymphoma (p less than 0.02) and in the group with various primary cancers (p less than 0.05). No difference was found between 46 patients tested under chemoradiotherapy and 216 patients who had not undergone therapy for at least 1 month. Four patients with clinical thrombosis had normal ATIII biologic activity. Of the 262 patients studied, 14 had low AT III biologic activity without clinical thrombosis and normal protein concentration. In 71 patients (27%) an excess of immunoassayable protein of 20% or more over biologic activity was found. Double immunoelectrophoresis performed in 5 of these showed for 3 patients an enlarged second are of precipitation. Moreover, no correlation was observed between the activity and protein AT III concentration (r = 0.05). The likelihood of the presence of circulating AT III-protease complexes is discussed.
Antithrombin III↗
Serum copper level in non-Hodgkin's lymphomas.
Serum copper level (SCL) was studied by the atomic absorption technique in 103 patients with non-Hodgkin's lymphoma. SCL was increased in 61% of patients at diagnosis or during active disease; values within normal range were found in 88% of patients in complete remission. The difference between mean SCL during active disease and in remission was highly significant, independently of stage and histologic type, so that: a) Within the same clinical stage high SCL at diagnosis was associated with poorer response to therapy in stage II and stage III (respectively P = 0.033 and P = 0.049), but not in stage IV, where the complete remissions were only 8 out of 42. A shorter 5-year survival was also shown in stages III and IV with high SCL at diagnosis (respectively P less than 0.025 and P less than 0.05), but not in stage II where the deaths were only 3 out of 24. b) Within histologic types, SCL is a useful prognostic index of response to therapy and survival, although a statistically significant difference was only reached for poorly differentiated lymphocytic lymphoma. We conclude that SCL may be a good parameter of disease activity and a useful index of response to therapy and survival in non-Hodgkin's lymphoma.
Adolescent↗
A planned prospective study of combined treatment in stage III epithelial ovarian cancer.
In a planned prospective study 39 consecutive patients with stage III ovarian cancer have been admitted in two years. All patients have received initial extensive surgery followed on as out patients basis by 5 courses of A-Cy chemotherapy and by a second operation and further non cross resistant chemotherapy with Platinum, Hexamethyl-Melamine, Polymelphalan; 24 have been found pathologically free of disease at second surgery, and 34/39 are clinically free of disease while reporting. These data, exactly collected and evaluated are consistent with our (previously reported) empyrical observation that adjuvant surgery interspersed with courses of aggressive chemotherapy may render free of disease the majority of patients, prolong survival, and possibly cure a portion of this population.
Adenocarcinoma↗
Tamoxifen treatment for advanced renal cell cancer.
Twelve patients with metastatic clear cell renal cancer received a course of tamoxifen. Three showed stable disease for a period from 2 to 12 months and 1 a mixed response for a short time. It does not appear that tamoxifen may be a useful agent in the treatment of metastatic renal cell carcinoma.
Adenocarcinoma↗
[Toxicity of high-dose bleomycin administered by continuous infusion].
Fifteen patients with nonseminomatous testicular cancer underwent multidrug treatment which included cis platinum, Velban and bleomycin. The latter drug was administered in monthly 5 day courses of 100 mg/m2. No impairment of antitumor effect resulted since 12 of 15 patients had remissions (10 complete and 2 partial). Pulmonary toxicity was practically abolished: a median dose of 675 mg per patient (range 450 to 1050) was followed by normal lung X-ray and normal or near normal functional parameters after completing treatment. Median arterial oxygen pressure was 78 mm Hg (range 62 to 89), and median Tiffeneau index was 84 (range 64 to 87). Only 2 of 15 patients had skin marks from bleomycin toxicity at the end of treatment, so that cutaneous toxicity was also very low. Oral mucosa reversible damage was prominent in 2 patients. On the contrary, alopecia was a common finding.
Adolescent↗