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PubMed1982

Levamisole as an adjuvant to chemotherapy in extensive bronchogenic carcinoma: a Veterans Administration Lung Cancer Group Study.

A randomized trial of 381 patients with extensive lung cancer compared immunochemotherapy with levamisole (150 mg/m2 orally three times a week), cyclophosphamide (700 mg/m2 IV every three weeks) and CCNU (70 mg/m2 orally every six weeks) with the same chemotherapy without levamisole. When disease progressed, doxorubicin hydrochloride or doxorubicin hydrochloride plus levamisole was used. Hematologic toxicity required reduction of the levamisole dosage to 2.5 mg/kg (100 mg/m2) three times a week, every other week. When corrections are made for all variables, levamisole itself had a negative influence on survival. Patients given 150 mg/m2 had a shorter median time to treatment failure (P = 0.02), lower response rate (P = 0.02) more toxicity (P = 0.08), and shorter median survival (P = 0.08). Patients with 10% or greater weight loss had significantly shorter survival (P = 0.006). The regimen with the reduced dosage of levamisole also was more toxic (P = 0.05) but otherwise did not differ from the control regimen. The cause of the adverse effect of levamisole is unknown. It did not occur because of an excess of toxic deaths or because smaller doses of cytotoxic drugs were given to patients treated with levamisole. Neither the initial lymphocyte count nor the Candida skin test reactions had a significant effect on the study endpoints when correction was made for dominant prognostic factors such as the initial performance status and weight loss.

Carcinoma, Bronchogenic↗
PubMed1982

Comparison of oral melphalan, CCNU, and BCNU with and without vincristine and prednisone in the treatment of multiple myeloma. Cancer and Leukemia Group B experience.

A total of 361 evaluable patients with previously untreated multiple myeloma were randomized to receive oral melphalan (0.15 mg/kg/day for seven days, followed by 0.05 mg/kg/day after recovery from the nadir of the leukocytes), BCNU (150 mg/m2 intravenously every six weeks) or CCNU (100 mg/m2 orally every six weeks). All patients received a tapering six-weeks) or CCNU (100 mg/m2 orally every six weeks). All patients received a tapering six-week course of prednisone starting at 0.8 mg/kg for the first two weeks. At week 22, one-half of the patients were randomized to receive vincristine (1 mg/m2) and prednisone (0.6 mg/kg for seven days) every two months in addition to previous therapy. The melphalan treated patients showed a significantly higher overall objective response frequency (59%), according to Myeloma Task Force criteria, when compared to those treated with BCNU (40%) or CCNU (42%). The survivals for all patients were not statistically different for the three treatment programs. However, the good-risk patients treated with melphalan had significantly longer survival (P = 0.02) than the equivalent patients who received BCNU or CCNU. The addition of vincristine and prednisone at week 2 did not significantly increase the percentage of subsequent objective responses or prolong the subsequent survival of any treatment group. It is concluded that oral melphalan is superior to BCNU and CCNU in producing objective responses and in prolonging survival in good risk patients.

Antineoplastic Agents↗
PubMed1982

Prolonged intermittent adjuvant chemotherapy with CCNU and hydroxyurea after resection of carcinoma of the lung.

Eight hundred sixty-five patients with a microscopically curative resection for carcinoma of the lung were accepted for study, none of whom were excluded from analysis. Adjuvant therapy was randomly assigned about the tenth to 14th postoperative day; 432 patients (treated) were to receive CCNU and hydroxyurea for one year, while 433 patients (controls) were to receive no adjuvant therapy. Toxic reactions to therapy were reported, but only 1% were severe enough to require stopping therapy. No evidence of improved survival or delayed recurrence of disease was seen in treated patients as a whole or when examined by cell type and by postsurgical TNM category. On the contrary, survival beyond the second year of follow-up may have been impaired by the drugs when administered to patients without evidence of tumor spread to the lymph nodes.

Carcinoma↗
PubMed1982

The clinical behavior of "mixed" small cell/large cell bronchogenic carcinoma compared to "pure" small cell subtypes.

Biopsy specimens from 19 previously untreated lung cancer patients were prospectively diagnosed as small cell carcinoma with a large cell component. The patients were thoroughly staged and received intensive combination chemotherapy. They represented 12% of all small cell carcinoma cases eligible for aggressive chemotherapy protocols during a 5.5 year period. To determine whether the clinical behavior of this "mixed" histologic variant differed from the other histologic subtypes of small cell lung cancer, we compared these 19 patients to a concurrent group of 103 patients with only small cell cancer in their diagnostic biopsies given equivalent therapy. The "mixed" histology patients were comparable to the "pure" small cell group in age, performance status, extent of disease, and frequency of bone marrow, liver, bone, and central nervous system metastases. Their complete plus partial response rare (58%) was significantly less than the response rate for the "pure" small cell patients (91%), their complete response rate was also lower (16 versus 46%), and their overall survival was significantly shorter (median, 6 versus 10.5 months) Mixed histology small cell/large cell carcinoma represents a distinct pathologic variant of small cell carcinoma of the lung, associated with lower response rates and shorter survival than the "pure" small cell subtypes. Since combination chemotherapy yields some complete responses and long-term disease-free survival in these patients, however, aggressive treatment with potentially curative intent should be considered in their management.

Adult↗
PubMed1983

Treatment of MOPP-refractory Hodgkin's disease with vinblastine, doxorubicin, bleomycin, CCNU, and dacarbazine.

Eighteen patients with advanced Hodgkin's disease, refractory to combination chemotherapy with nitrogen mustard, vincristine, prednisone, and procarbazine (MOPP), were treated with vinblastine, doxorubicin (Adriamycin), bleomycin, CCNU, and dacarbazine (DTIC) (VABCD). Fifteen patients had Stage IV disease and 11 had systemic symptoms. Although hematologic toxicity was considerable, there was no drug related mortality. Eight patients achieved a complete remission (CR), and five are currently in a continuous CR of five, 24, 30, 34, and 36 months duration, respectively. An additional patient had a 30-month CR and relapsed with localized lymphadenopathy and is currently disease-free following involved-field radiotherapy 46 months from initiation of VABCD. This study suggests that long-term disease-free survival and potential cure can be achieved with VABCD in MOPP-refractory Hodgkin's disease.

Adolescent↗
PubMed1983

Pulmonary fibrosis subsequent to high doses of CCNU for chronic myeloid leukemia.

Two patients treated for chronic myeloid leukemia with high doses of CCNU (1100 mg/m2 and 1240 mg/m2, respectively) developed a fatal pulmonary fibrosis. This side effect has never been reported for this nitrosourea but only for BCNU and methyl-CCNU. The responsibility of CCNU in the pathogenesis of pulmonary fibrosis seems very likely. The possibility that the underlying disease or other chemotherapeutic agents may increase the risk of pulmonary toxicity can, however, be discussed. In addition, 13 other adults treated for chronic myeloid leukemia with various doses of CCNU were reviewed. No respiratory symptoms appeared in the ten patients who were given less than 950 mg/m2. Three patients who received more than 1100 mg/m2 developed pulmonary symptoms with the same clinical and radiologic pattern as in the two cases with pathologic documents, and two of them died from acute respiratory failure. Although lung specimens were lacking from these three patients, it is suggested that the pulmonary toxicity of CCNU may be dose-related.

Adult↗
PubMed1983

Diagnosis and management of Hodgkin's disease in the adult.

Appropriate management of Hodgkin's disease is based on both the stage of disease and the specific anatomic sites of involvement within each stage. As a result of the combination of sequential staging and effective treatment, histopathologic subclassification has become less important. Although not generally appreciated, this is also true for constitutional symptoms. During the past 15 years, differences in survival between early and advanced stages have diminished progressively with refinements both in management of newly diagnosed patients, and in management of relapsing disease. Currently, our five-year survival figure for laparotomy-Staged I and II patients is 95%. The corresponding result for Stages IIIA and IIIB patients is 85%; and 67% of our Stage IV patients, who were treated with mechlorethamine, vincristine, procarbazine, and prednisone (MOPP) are projected to be surviving at five years. With the anticipation of a high probability for cure, quality of life including the possibility for parenthood has become increasingly important. In the past, the trend has been to increase treatment for patients with poor prognostic factors. However, very little attention has been paid to the possibility of administering less treatment for very precisely staged patients with good prognostic factors. In this review, management is discussed by stage. Emphasis is placed on the indications for less treatment as well as for more intensive therapy in adult patients with Hodgkin's disease.

Antineoplastic Agents↗
PubMed1983

Metastasis of an optic glioma through a ventriculoperitoneal shunt.

Metastatic spread of an optic glioma through a ventriculoperitoneal shunt resulted in the accumulation of malignant ascites in a young boy. Chemotherapy with vincristine, CCNU, and prednisone resulted in regression of the ascites and no further tumor progression. Extracranial metastasis of such a slow growing tumor is a rare occurrence; however, in this case, the spread through the shunt further emphasizes the need for protective filters in the shunts.

Antineoplastic Agents↗
PubMed1983

Doxorubicin and CCNU with or without vincristine in patients with advanced refractory breast cancer. A randomized trial.

Thirty-five patients with advanced breast cancer refractory to initial chemotherapy were randomized to receive two-drug doxorubicin-CCNU or three-drug doxorubicin-CCNU-vincristine (VCR) treatment. Doxorubicin (25-40 mg/m2) and VCR (1.4 mg/m2) were given intravenously every 21 days; CCNU (65-90 mg/m2) was given orally every 42 days. Patients with liver or bone marrow metastases initially received the lower range doses. All patients failed prior chemotherapy with cyclophosphamide and 5-FU with or without methotrexate and prednisone; 67% received prior hormonal therapy. Pretreatment patient characteristics were comparable in both groups. Objective responses (greater than 50% reduction in tumor size) were seen in 7 of 18 patients (39%) on the VCR containing arm and in 8 of 17 patients (46%) on the doxorubicin-CCNU arm. Survival was not improved by VCR addition with overall survival on the doxorubicin-CCNU arm, approximately 10% greater at all intervals (median 9.1 versus 7.0 months; not statistically significant). However, neurotoxicity was significantly greater in the VCR arm (36% versus 0%; P less than 0.05). In advanced breast cancer, no benefit to VCR addition was seen in prior randomized studies of first-line combinations where VCR was the treatment variable. Such results, combined with our experience with VCR in a salvage regimen, question the value of VCR addition to combination regimens in advanced breast cancer.

Breast Neoplasms↗
PubMed1983

Early response to chemotherapy as a prognostic factor in Hodgkin's disease.

In 164 patients with Hodgkin's disease staged between 1973 and 1979 the response to the 3 initial cycles of multiagent chemotherapy was evaluated as a prognosticator of survival. Treatment of localized disease (Stages I, II, III1) consisted of 3 cycles of chemotherapy followed by subtotal nodal irradiation, including the splenic area in non splenectomized patients. Treatment of extended disease (Stage III2 and IV) consisted of 6 cycles followed by low-dosage radiotherapy of initial bulky disease. Five-year actuarial survival was 88% in Stage I, 80% in II, 100% in III1, 45% in III2 and IV. Chemotherapy-induced complete remission after 3 cycles (CH leads to CR) was associated with a favorable prognosis. Five-year survival of Stage III2 and IV patients was better in those who reached CH leads to CR than in those who did not (75% versus 25%; P less than 0.01). This relationship between CH leads to CR and five-year survival was confirmed in patients with localized disease, as shown in Stage II patients (respectively 97% versus 63%; P less than 0.05). Therefore the response to initial chemotherapy provides a new prognostic factor that may serve to delineate a "high-risk" group of patients. The latter deserve aggressive therapy while those in the favorable group would benefit from a less aggressive combined regimen that would minimize long-term complications.

Antineoplastic Agents↗
PubMed1984

Small cell lung cancer and the influence of chemotherapy on CFUcs in bone marrow.

To determine the optimal moment for the harvesting of bone marrow for autologous transplantation, the authors did serially colony forming units in culture (CFUc) counts in a group of 42 patients with small cell lung cancer (SCLC) before and after remission induction chemotherapy and subsequent maintenance chemotherapy. Disease stage did not influence the CFUc count except in patients with bone marrow metastases; this resulted in either abnormally low or abnormally high CFUc counts, probably dependent on the degree of invasion. After 2 courses of induction chemotherapy, the number of CFUcs was 3.1-fold higher than before therapy. After 4 courses, the CFUcs number was comparable to the pretreatment value. An inverse correlation was found between the degree of hematologic toxicity (expressed as leucocytes count) and the increase of CFUcs after induction chemotherapy. The number of CFUcs decreased during prolonged chemotherapy to low levels after 1 year. Harvesting of bone marrow is probably done best shortly after induction chemotherapy.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1984

Dimethyl triazeno imidazole carboxamide and combination therapy for melanoma. IV. Late results after complete response to chemotherapy (Central Oncology Group protocols 7130, 7131, and 7131A).

The results of three Phase III studies of DTIC in 580 patients with metastatic melanoma were reviewed to evaluate the subsequent course of 26 patients who achieved a complete response (CR) to chemotherapy. The majority (17 of 26) of these patients had soft tissue metastases. Six of the 26 patients remained in CR at last report (30-259 weeks), two died of other causes while remaining free of melanoma, and 18 relapsed and died. Ninety-five percent of the 26 patients were alive at 1 year, and survival was 31.1% at 72 months. Seven of the eight patients with sustained remission received chemotherapy for at least 6 months after CR developed, whereas 10 of 18 relapsing patients were treated for less than 6 months after CR was achieved. Long-term sustained CR to chemotherapy occurs in 1% to 2% of patients treated with DTIC, and late relapse is rare in patients who remain in CR for 2 years.

Adult↗
PubMed1984

Medulloblastoma. Results of a sequential combined treatment.

Actuarial progression-free survival rate at 5 years of a series of 34 patients with medulloblastoma treated by combined surgery, radiotherapy, and chemotherapy was 71%. No relapses were observed in 14 patients followed for more than 5 years. Treatment consisted of a short postoperative course of vincristine (VCR) and intrathecal (IT) methotrexate (MTX) followed by irradiation to the entire cranio spinal axis. Maintenance chemotherapy (CCNU, VCR, and IT MTX) was then continued to encompass 2 years from surgery. Failure occurred in nine patients: four had local recurrence, four dissemination within the central nervous system, and one widespread skeletal metastases. Poor prognostic factors such as presence of malignant cells in the cerebrospinal fluid, non-radical surgery, young age, and radiation doses less than 50 Gy to the tumor bed, did not adversely affect the outcome of patients in this series. Long-term sequelae from the treatment program could be observed in all patients, and in 58% they were severe enough to interfere with normal, active life.

Adolescent↗
PubMed1984

Combined modality in Hodgkin's disease. Comparison of six versus three courses of MOPP with clinical and surgical restaging.

Between 1972 and 1979, 121 patients with Hodgkin's disease (clinical Stages IInA, IB, IIB, and III) were treated by two different, successive, therapeutic protocols. The first group received six MOPP (mechlorethamine, vincristine, procarbazine, prednisone) cycles before radiotherapy, whereas the second group received only three MOPP cycles before irradiation. A total of 118 patients underwent surgical restaging with splenectomy before irradiation. Clinical criteria used in defining complete remission were verified by surgical restaging. Three MOPPs were just as effective as six MOPPs when combined with radiotherapy in achieving complete remission and in treating occult splenic disease. Following extended-field irradiation, complete remission rates were 96% for three MOPPs versus 94% for six MOPPs. The actuarial survival rates, 4 years after therapy completion, were 89% for three MOPPs and 94% for six MOPPs, with a relapse-free survival rate of 88% and 96.6%, respectively.

Adolescent↗
PubMed1985

The role of radiation therapy in the treatment of small cell lung cancer.

Patients with small cell lung cancer (SCLC) are candidates for aggressive therapy because of their potential for long-term survival, especially patients with limited-stage disease. Although no treatment protocol can be considered "standard", the best results in limited-stage SCLC appear to be produced by a combination of chemotherapy and thoracic irradiation. Ongoing protocols testing the efficacy of thoracic irradiation should be able to settle question of the optimal treatment approach in limited-stage SCLC over the next 1 to 2 years. Careful attention to volume treated and the use of shrinking fields produce the best results with the minimum of toxicity. Treatment of extensive-stage SCLC has not been substantially improved to date with the addition of local or systemic irradiation. Prophylactic cranial irradiation reduces the incidence of CNS failure in SCLC and should be given, at a minimum, to patients achieving complete response status. Whether patients with partial response should also receive prophylactic cranial irradiation remains controversial. Finally, half-body radiation in SCLC is an experimental research technique that has shown some promise but remains quite toxic when combined with systemic chemotherapy.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1985

The use of BELD combination chemotherapy (bleomycin, vindesine, CCNU, and DTIC) in advanced malignant melanoma.

Twenty-one patients with Stage III malignant melanoma have been treated with a 5-day quadruple chemotherapy regime (BELD) comprising bleomycin 15 mg subcutaneously on days 1 and 4, vindesine (Eldesine) 3 mg/m2 intravenously on days 1 and 5, CCNU (lomusine) 80 mg/m2 orally on day 1, and DTIC 200 mg/m2 intravenously on days 1 through 5. Twenty patients were evaluated after two cycles. Three (15%) are in complete remission 12, 16, and 53 weeks after therapy, respectively, and six (30%) experienced worthwhile partial remissions. This combined response rate of 45% is considerably better than that seen in single- or dual-agent chemotherapy. Toxicity was acceptable, and several patients received their therapy on an outpatient (ambulatory) basis. The one nonevaluable patient had radiotherapy for an isolated spinal metastasis and two courses of BELD. She is well and pain- and disease-free 56 weeks later. The median survival for all treated patients is 43 weeks, and the median follow-up time is now 63 weeks.

Adult↗