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PubMed1985

Melanoma: therapeutic options with recombinant interferons.

Melanoma is a neoplasm of rising incidence, especially in people under 35 years of age. It is a neoplasm for which we lack effective treatments after failure of definitive surgery. The strong rationale for immunologic intervention and encouraging early results obtained with recombinant interferons in multiple trials of patients with advanced melanoma are reviewed. Criteria for evaluation of response to interferons, which ideally include a minimum treatment duration of 3 months, liken this modality to endocrine therapy of other cancers. Objective regression has been obtained in 20% of patients entered into trials of recombinant interferon alfa-2a and alpha-2b. More interestingly, the fraction of all responses with alfa-2a and alfa-2b that are complete responses is nearly one third; these complete responses have proven to be extremely durable (1 + to 3+ years) in several independent trials. Trials in progress to determine the effects of recombinant alpha interferons in the adjuvant setting of high-risk stage II (lymph node metastatic) or stage I (deep primary) melanoma are noted. The rationale and trial designs for combined trials of interferons of different types (alpha or beta plus gamma), interferons plus more tumor-specific antibodies, and interferon-chemotherapy combinations are presented. Recombinant interferons have achieved a place in the developmental armamentarium of medical oncology for melanoma--and phase III trials to compare the relative effects of decarbazine or semustine and interferon alpha are under way. The challenge now is to understand the mechanism of action for interferons, which may optimize the effects of the substance alone, and for interferon use in combination with other agents, such as antibodies, whose effects may be enhanced when used in conjunction with interferon treatment.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1988

Prognostic factors for survival in hepatocellular carcinoma.

Associations between patient characteristics and survival were investigated in 432 patients with hepatocellular carcinoma. Those patients were prospectively studied by the Eastern Cooperative Oncology Group, and each had his or her diagnosis reconfirmed by a pathology review panel. There were 301 North American and 131 South African patients. Sixty-nine % of the North American patients and 82% of the South African patients were male. There were 187 Black patients, 62 of whom were from North America. The study population is unique among hepatocellular carcinoma patients in that eligibility, evaluability, and endpoint definitions were standardized, and patients from both North America and South Africa received similar treatments at a similar time. Factors with the most significant adverse effect on survival are impaired performance status, male sex, older age, and disease symptoms (jaundice and reduced appetite). There is no apparent difference in survival between White and Black patients within North America, but North American patients survived longer than South African patients. Among the different therapies, p.o. 5-fluorouracil was associated with the poorest median survival time (6 wk), and i.v. 5-fluorouracil plus semustine with the best median survival time (24 wk).

Adult↗
PubMed1987

Survey of the effect of adding Fluosol-DA 20%/O2 to treatment with various chemotherapeutic agents.

The tumor growth delays (TGDs) observed with a series of antineoplastic agents with or without Fluosol-DA and carbogen breathing (95% oxygen, 5% carbon dioxide) in the FSaIIC fibrosarcoma are shown. All but two of eleven alkylating agents examined showed some degree of positive effect by the addition of Fluosol-DA and carbogen breathing to drug treatment. The largest effects were seen with busulfan and procarbazine. Melphalan and the nitrosoureas, carmustine, lomustine, semustine, and chlorozotocin, gave increases in TGD ranging from 2- to 6-fold with the addition of Fluosol-DA and carbogen breathing. Modest increases were seen with cytoxan and dacarbazine. Cisplatin showed no additional TGD with Fluosol-DA and carbogen breathing, and mitomycin showed a negative effect. The addition of Fluosol-DA and carbogen breathing to bleomycin treatment increased the TGD produced by 5- to 6-fold compared to the drug alone. With vincristine and etoposide at three different doses, TGDs increased 2.4- to 3-fold in combination with Fluosol-DA and carbogen breathing. Increases of 1.3- to 1.4-fold in the TGD were observed with methotrexate and 5-fluorouracil with Fluosol-DA and carbogen breathing. Adding Fluosol-DA and carbogen breathing to treatment with several of the drugs examined resulted in significant enhancement of TGD and therefore may lead to an improved therapeutic outcome when added to certain currently used clinical regimens.

Alkylating Agents↗
PubMed1988

Combined modality approach to treatment of malignant gliomas--re-evaluation of RTOG 7401/ECOG 1374 with long-term follow-up: a joint study of the Radiation Therapy Oncology Group and the Eastern Cooperative Oncology Group.

The Radiation Therapy Oncology Group (RTOG) and the Eastern Cooperative Oncology Group (ECOG) conducted a phase III trial in patients with malignant gliomas to evaluate 4 treatment arms: 1) 60 Gy to the whole brain; 2) 60 Gy plus 10-Gy boost; 3) 60 Gy plus carmustine (BCNU); and 4) 60 Gy plus semustine plus dacarbazine. Between September 1974 and March 1979, 626 patients with malignant gliomas were treated on protocol RTOG 7401/ECOG 1374. Each institution chose a subset of the treatments to which the patients would be randomized. Patients were stratified according to subset and randomized to the 4 treatment arms. There were no differences in survival among treatment arms. For patients greater than 60 years of age, the addition of chemotherapy to radiation therapy did not improve survival. For patients aged 40-60 years, there was a statistically significant increase in overall survival when BCNU was added to 60 Gy (P less than .01), with an increase in 2-year survival from 8% to 23%. This beneficial effect of BCNU is apparent in both histological groups (astrocytoma with atypical or anaplastic foci and glioblastoma multiforme). Although few confirmatory autopsies are available, long-term survival in patients with astrocytomas with atypical and anaplastic foci who were treated with 60 Gy plus BCNU (5-yr survival, 22%) suggests no significant late CNS toxicity, compared to 60 Gy alone (5-yr survival, 15%). This is confirmed by comparable neurological function in long-term survivors.

Adult↗
PubMed1993

Adjuvant treatment for rectal cancer: current status.

Surgery is still the cornerstone of curative treatment for rectal cancer. A combination of postoperative radiation and chemotherapy is the preferred adjuvant treatment for TNM stages II and III rectal cancer. Although studies combining 5-fluorouracil (5-FU) and the investigational agent semustine (methyl-CCNU) with radiation showed some survival benefit, preliminary results of recent studies suggest that radiation with 5-FU alone is an effective substitute. Preoperative radiation treatment has several advantages over postoperative radiotherapy. The major disadvantage, that tumors may be downstaged, preventing exact evaluation of treatment results, may be overcome by using rectal ultrasound for preoperative staging. Another promising treatment is preoperative radiation combined with 5-FU as a radiosensitizer and for possible increased systemic effect. Studies are needed to find a better, less toxic radiosensitizer, to explore new chemotherapy combinations with 5-FU (such as levamisole), and to define the proper dose sequence and integration.

Combined Modality Therapy↗
PubMed1997

Adjuvant therapy for stage III colon cancer after complete resection. Provincial Gastrointestinal Disease Site Group.

GUIDELINE QUESTIONS: Should patients with resected stage III colon cancer receive adjuvant therapy? If so, which therapy should be recommended? OBJECTIVE: To make recommendations regarding the use of adjuvant therapy in the treatment of resected stage III colon cancer. OUTCOMES: Overall survival is the primary outcome of interest. Secondary outcomes are disease-free survival and adverse effects of the treatment regimens. PERSPECTIVE (VALUES): Evidence was selected and reviewed by 4 members of the Gastrointestinal Disease Site Group (GI DSG) of the Ontario Cancer Treatment Practice Guidelines Initiative. Earlier drafts of the guideline were reviewed, discussed and approved by the GI DSG, which comprises medical and radiation oncologists, surgeons and epidemiologists. Community representatives did not participate in the development of this guideline but will participate in future guidelines development. QUALITY OF EVIDENCE: There are 3 meta-analyses, 33 published randomized controlled trials (RCTs) and 1 consensus statement. The GI DSG pooled data from 10 of the 33 RCTs that allowed for such an analysis. BENEFITS: Two of 3 RCTs reported improved survival rates with 5-fluorouracil (5-FU) plus semustine or mitomycin C (MMC) compared with no treatment (observation) after surgical resection. Three trials reported a benefit in both overall and disease-free survival with 5-FU plus levamisole compared with observation after surgery. In 2 trials, levamisole alone did not produce a survival benefit compared with observation. One trial reported improved disease-free, but not overall, survival rates with oral HCFU (1-hexylcarbamoyl-5-fluorouracil) compared with observation. In 3 trials of 5-FU plus leucovorin, disease-free and overall survival rates were improved compared with observation. Nine trials compared portal vein infusion (PVI) of 5-FU with observation after surgery. In 2 of the trials, for which data were available for stage III patients only, improved overall survival was reported. There was a trend in all studies favouring PVI. One trial reported a survival benefit for stage III and IV patients who received oral HCFU maintenance therapy for 1 year compared with no maintenance therapy. In a trial comparing MMC plus oral HCFU with MMC alone, a survival benefit was reported in the combined treatment group; however, the stages of cancer were unevenly distributed among the treatment groups. Only 1 study tested monoclonal antibody; a benefit was reported for both overall and disease-free survival. A meta-analysis of 10 trials comparing adjuvant therapy with observation in patients with stage III disease detected a significant reduction in the odds ratio (OR) for death (OR 0.69; 95% confidence interval [CI] 0.57 to 0.85), with an absolute improvement in survival of 4% to 13%. When trials were separated according to the type of treatment given, the significant ORs were for 5-FU plus either levamisole (OR 0.61; 95% CI 0.46 to 0.80) or leucovorin (OR 0.51; 95% CI 0.36 to 0.73). Three recently reported trials comparing various combinations of 5-FU plus leucovorin, with or without levamisole, showed similar improvements in disease-free and overall survival.

Chemotherapy, Adjuvant↗
PubMed1976

Chemotherapy of childhood medulloblastoma.

A number of chemotherapeutic agents have been shown to have anti-tumor activity against childhood medulloblastoma. Ten-year survival with optimal surgery and radiation therapy ranges from 5% to 25%. Carefully controlled clinical trials utilizing a combination of surgery, radiation therapy, and chemotherapy should be employed in the early stages of the disease in an attempt to define which drugs are most effective, and to improve the survival rate.

Adolescent↗
PubMed1975

COMB (cyclophosphamide, oncovin, methyl-CCNU, and bleomycin): a four-drug combination in solid tumors.

One hundred eighty-nine patients received a four-drug combination consisting of cyclophosphamide, Oncovin (vincristine), methyl CCNU, and bleomycin (COMB), according to three different drug regimens, performed sequentially. Of the 189, 62 had a partial response (33%) including 11/33 with squamous lung cancer, 11/32 with squamous carcinoma of the head and neck, 13/15 with oat cell carcinoma of the lung, and 7/41 with malignant melanoma. The response rate for patients with squamous lung or head and neck cancer appeared to be higher at weekly bleomycin doses of 30 and 60 mg (15/33 = 45%), compared to a weekly bleomycin dose of 15 mg (7/32 = 25%). A median survival from treatment of 30 weeks was observed in oat cell carcinoma, which represents considerable prolongation over that expected from supportive care alone or single-agent chemotherapy. Toxicity included: 1) myelosuppression, resulting in hospitalization for antibiotics in 20% of patients; 2) probable bleomycin lung damage in 4% of patients; and 3) dose-limiting vincristine neuropathy in 11%. The combination of twice-weekly vincristine and bleomycin for more than 6 weeks produced a disturbing "debilitation syndrome," characterized by weakness, anorexia, weight loss, and apathy. The encouraging response rate suggests a future role for these drugs in combination, especially for vincristine and bleomycin, with other agents showing activity in squamous and oat cell carcinoma. Toxicity precludes recommendation of this combination, in the regimens tested, for broader Phase III studies.

Bleomycin↗
PubMed1975

Chemotherapy of large intestinal carcinoma. Current results and future prospects.

Chemotherapy of advanced stages of large bowel cancer has until recently made little progress since the introduction of 5-FU 16 years ago. While survival is improved for patients who respond, 5-FU alone has made little impact on life span of the overall population of patients. Mitomycin-C and the chloroethyl nitrosourea antitumor agents, and in particular methyl-CCNU, have also demonstrated marginal activity in large bowel cancer. Two recently reported controlled clinical trials of combination chemotherapy have demonstrated response rates that are substantially better than those obtained with 5-FU alone; a 43% response rate in colorectal carcinoma has been reported using a combination of 5-FU, BCNU, vincristine, and DTIC, compared to a 25% response with 5-FU as a single agent; a 44% objective response rate with a combination of 5-FU, methyl-CCNU, and vincristine has been reported to be significantly better than 5-FU alone. 5-FU as an adjuvant following surgical resection with curative intent has not prevented tumor relapse; however, it is hoped that future studies employing more effective drug combinations will result in increased number of patients achieving disease free survival.

Administration, Oral↗
PubMed1976

A phase II study of intravenously- administered methyl CCNU in the treatment of advanced sarcomas.

Thirty-two patients with advanced, inoperable nonhematologic soft-tissue and osseous sarcomas were treated with Methyl CCNU administered via controlled intravenous infusion in doses of 130-170 mg/m2 every 6 weeks in a Phase II trial. All 28 evaluable patients were no longer responsive to adriamycin. Greater than 50% tumor regression was seen in one of two patients with chondrosarcoma and one of five patients with rhabdomyosarcoma. Less than 50% tumor regression occurred in one of five patients with rhabdomyosarcoma, one of two patients with malignant giant cell tumor, and one of three patients with malignant fibrous histiocytoma. Stabilization of previously advancing disease occurred in two of seven patients with leiomyosarcoma. The drug preparation was well tolerated. Nausea and vomiting occurring in three of 32 patients. Major toxicity was myelosuppression, characterized chiefly by thrombocytopenia with lesser degrees of leukopenia. This drug preparation appears to have activity in this group of tumors.

Clinical Trials as Topic↗
PubMed1976

Phase III comparison of the treatment of advanced gastrointestinal cancer with bolus weekly 5-FU vs. methyl-CCNU plus bolus weekly 5-FU. A Southwest Oncology Group study.

In a randomized and stratified study, 294 patients with advanced gastrointestinal cancer were treated either with 5-fluorouracil (5-FU) 400 mg/m2 weekly intravenously (i.v.) or 5-FU 400 mg/m2 i.v. weekly plus methyl-CCNU 175 mg/m2 orally (p.o.) every 6 weeks. The response rate in colorectal cancer with 5-FU was 9.5% while the two-drug treatment produced a response of 31.8% (p=.009). The response in all gastrointestinal cancers to 5-FU was 10.6% as compared with29.3% for the combination (p=.012). All responses were partial. The two-drug regimen is more effective and more toxic than weekly 5-FU therapy.

Adolescent↗
PubMed1976

Sequential and combination chemotherapy of advanced gastric cancer.

One hundred and forty-six previously untreated patients with advanced gastric cancer were assigned at random to therapy with the following regimens: 1) Methyl CCNU alone; 2) Methyl CCNU with cyclophosphamide induction; 3) 5-fluorouracil (5-FU) + methyl CCNU; and 4) 5-FU + methyl CCNU with cyclophosphamide induction. Cyclophosphamide induction produced an objective response rate of only 8%. In addition, it added to hematologic toxicity and detracted from the therapeutic activity of subsequent treatment. Methyl CCNU was relatively ineffective therapy with an overall objective response rate of 8%. The response rate to 5-FU + methyl CCNU without cyclophosphamide induction was 40% and this was significantly superior to all other regimens. The survival time of all patients treated with 5-FU + methyl CCNU was significantly superior to that of all patients treated with methyl CCNU alone.

Adenocarcinoma↗
PubMed1976

Adjuvant chemotherapy in the surgical treatment of large bowel cancer.

In two large controlled cooperative trials, 1118 patients undergoing surgical resection for large bowel cancer were randomized to be treated by surgery alone or to receive 5-fluorouracil during postoperative followup. The two studies differed slightly in the selection of patients for entry and in the dose regimens of 5-fluorouracil. Following examination of the removed specimen, "curative" and palliative stratifications based on evidence of residual disease were made, so that the two trials actually consisted of five separate patient groups, two groups of patients who had "curative" resections and the other three smaller groups of patients who had palliative resections with residual disease or tumor at a margin of the resected specimen. In all five groups, survival was slightly better in patients receiving chemotherapy although no single difference is statistically significant. Any suggestion that these slight advantages represent a true therapeutic 5-FU effect must be tempered by previous negative adjuvant studies by this group as well as others. Currently the group is conducting a trial using a combination of methyl-CCNU and 5-fluorouracil and has recently added a nonspecific immunostimulant, methanol extraction residue of BCG (MER), to one subgroup.

Clinical Trials as Topic↗
PubMed1976

Fluorouracil, methyl-CCNU and vincristine in cancer of the colon.

In a randomized study 91 patients with metastatic cancer of the colon were treated with either fluorouracil alone or a combination of fluorouracil, methyl-CCNU, and vincristine. Of those treated with the three-drug combination, 37% responded, and of those treated with fluorouracil alone, 22% responded. Median response duration for patients treated with the combination method was 5.0 months and for those with fluorouracil alone, 3.8 months. Toxic effects are also compared. From this study it is concluded that a three-drug regimen provides a definite advantage.

Clinical Trials as Topic↗
PubMed1976

Cyclophosphamide, vincristine and procarbazine in the treatment of malignant melanoma.

Patients with advanced malignant melanoma were randomly assigned to treatment with cylcophosphamide and vincristine (CV) or cyclophosphamide, vincristine, and procarbazine (CVP). The objective response rates to each regimen (CV 30%, CVP 33%) were the same. Patients with disease confined to skin, subcutaneous tissue nodes, lung, or pleura had a significantly superior response rate to that in those with disease involving liver, bone or brain. The survival of responders was superior to that of nonresponders. The efficacy and moderate toxicity of CV suggests that further work with this combination in malignant melanoma is indicated.

Adult↗
PubMed1977

Therapy of advanced squamous carcinoma of the lung: cyclophosphamide vesus "COMB".

The four-drug combination of cyclophosphamide, vincristine, methyl CCNU and bleomycin was compared to CTX alone in a prospective randomized trial. Only one of 20 patients treated with COMB and one of 27 patients treated with CTX achieved a partial response. CTX was associated with a significantly better survival than COMB among patients who were ambulatory at onset of therapy. Survival among non-ambulatory patients was similar with both regimens.

Aged↗
PubMed1977

Gastrointestinal cancer--colon (surgery-radiotherapy). The role of radiation therapy in the management of rectosigmoid cancer.

The lack of an improvement in the gross survival statistics for colorectal cancer during the last decade and the negative results of randomized trials, suggests that 5-FU used as an adjuvant treatment has not increased survival. Current chemotherapeutic drug combinations, however, may prove effective in the adjuvant situation. The adjuvant use of preoperative radiation has shown improved survival in one randomized study and no change in the second study. Current preoperative radiotherapy studies using a more effective radiation dose will confirm the effect of preoperative radiation both on the primary tumor control and on metastases. Current postoperative adjuvant trials incorporating radiation, chemotherapy or a combination of the two, when completed, will provide clear indications for the physician as to the optimum treatment of Duke's B and C cancer of the colorectum. Three national randomized studies for inoperable, recurrent or residual carcinoma of the colorectum are testing the effect of radiation alone or in combination with chemotherapy or chemotherapy followed by immunotherapy.

Clinical Trials as Topic↗