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PubMed2001

Busulfan plus cyclophosphamide compared with total-body irradiation plus cyclophosphamide before marrow transplantation for myeloid leukemia: long-term follow-up of 4 randomized studies.

In the early 1990s, 4 randomized studies compared conditioning regimens before transplantation for leukemia with either cyclophosphamide (CY) and total-body irradiation (TBI), or busulfan (Bu) and CY. This study analyzed the long-term outcomes for 316 patients with chronic myeloid leukemia (CML) and 172 patients with acute myeloid leukemia (AML) who participated in these 4 trials, now with a mean follow-up of more than 7 years. Among patients with CML, no statistically significant difference in survival or disease-free survival emerged from testing the 2 regimens. The projected 10-year survival estimates were 65% and 63% with Bu-CY versus CY-TBI, respectively. Among patients with AML, the projected 10-year survival estimates were 51% and 63% (95% CI, 52%-74%) with Bu-CY versus CY-TBI, respectively. At last follow-up, most surviving patients had unimpaired health and had returned to work, regardless of the conditioning regimen. Late complications were analyzed after adjustment for patient age and for acute and chronic graft-versus-host disease (GVHD). CML patients who received CY-TBI had an increased risk of cataract formation, and patients treated with Bu-CY had an increased risk of irreversible alopecia. Chronic GVHD was the primary risk factor for late pulmonary disease and avascular osteonecrosis. Thus, Bu-CY and CY-TBI provided similar probabilities of cure for patients with CML. In patients with AML, a nonsignificant 10% lower survival rate was observed after Bu-CY. Late complications occurred equally after both conditioning regimens (except for increased risk of cataract after CY-TBI and of alopecia with Bu-CY).

Adolescent↗

PubMed1986

A randomized trial comparing cisplatin plus cyclophosphamide versus cisplatin, doxorubicin, and cyclophosphamide in advanced ovarian cancer.

After primary surgery, 125 patients with epithelial ovarian cancer (International Federation of Gynaecology and Obstetrics [FIGO] 1c + IIb + IIc = 22 patients, FIGO III = 82 patients, FIGO IV = 21 patients) were randomly allocated to receive PC (cisplatin 50 mg/m2 + cyclophosphamide 600 mg/m2 on day 1 every 28 days) (corrected) or PAC (PC + doxorubicin 45 mg/m2). After six cycles, patients clinically disease-free or with resectable residual disease were submitted to second-look surgery. After restaging, patients in surgical complete response (CR) stopped treatment while those responding partially (PR) received six more courses; patients whose disease progressed were excluded from the study. Among patients with measurable disease, the following clinical response rates were observed: PC = 20% CR, 34.3% PR, 14.3% stable disease, and 31.4% progression; PAC = 40.6% CR, 15.6% PR, 12.5% stable disease, and 31.3% progression. In the 75 patients submitted to second look, the results have been the following: PC = 39.5% CR, 36.8% PR, 7.9% stable disease, and 15.8% progression; PAC = 62.2% CR, 18.9% PR, 10.8% stable disease, and 8.1% progression. The difference in surgical complete response in favor of the PAC regimen is significant (P less than .05). Median survival and progression-free survival were 800 and 400 days, respectively, for PAC arm; median survival and progression-free survival were 680 and 380 days, respectively, for PC. These differences are not significant. Probability of survival was affected by FIGO stage, amount of residual disease, histology, performance status, and response at second look, while no influence was observed according to grade of tumor differentiation and age. Our results demonstrate the usefulness of doxorubicin in terms of surgical CR.

Adult↗

PubMed1988

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↗

PubMed2003

Final results of a randomized phase III trial comparing cyclophosphamide, epirubicin, and fluorouracil with a dose-intensified epirubicin and cyclophosphamide + filgrastim as neoadjuvant treatment in locally advanced breast cancer: an EORTC-NCIC-SAKK multicenter study.

PURPOSE: To compare the efficacy of a standard anthracycline-based regimen to a dose-intensified anthracycline regimen in locally advanced breast cancer. PATIENTS AND METHODS: Locally advanced breast cancer patients were randomly assigned onto a study comparing cyclophosphamide (C; 75 mg/m(2) orally days 1 to 14), epirubicin (E; 60 mg/m(2) intravenously [IV] days 1, 8), and fluorouracil (F; 500 mg/m(2) IV days 1, 8) six cycles every 28 days versus E (120 mg/m(2) IV day 1), C (830 mg/m(2) IV day 1), and granulocyte colony-stimulating factor (filgrastim; 5 micro g/kg/d subcutaneously days 2 to 13) six cycles every 14 days. The study was designed to detect a 15% improvement; that is, from 50% to 65% in median progression-free survival (PFS) in favor of the dose-intensified regimen. RESULTS: A total of 448 patients were enrolled over a period of 3 years. The median dose intensity delivered for C and E reached, respectively, 85% and 87% of that planned in the CEF arm and 96% and 95% of that planned in the EC arm. The dose-intensified arm was slightly more emetogenic and generated more grade 3 to 4 anemia but less febrile neutropenia episodes. After a median follow-up of 5.5 years, 277 events have been reported. The median PFS was 34 and 33.7 months for CEF and EC, respectively (P =.68), and the 5-year survival rate was 53% and 51% for CEF and EC, respectively (P =.94). CONCLUSION: Dose-intensified EC does not provide a measurable therapeutic benefit over CEF as neoadjuvant chemotherapy for unselected locally advanced breast cancer patients.

Adolescent↗

PubMed1993

Busulfan and cyclophosphamide versus cyclophosphamide and total body irradiation for marrow transplantation in chronic myelogenous leukemia--a review.

Allogeneic bone marrow transplantation (BMT) for chronic myelogenous leukemia (CML) offers the only significant chance of cure for this disease. About 50% of patients transplanted in the 1980s appear to be cured and with subsequent advances, it is suggested that more patients transplanted in the 1990s will be cured. Cyclophosphamide (Cy) (120 mg/kg) followed by fractionated total body irradiation (TBI) (Cy2/TBI) has been usually employed in preparation for BMT. Alternative regimens of Busulfan (Bu) (16 mg/kg) and Cy (120 mg/kg) (Bu/Cy2) or Bu (16 mg/kg) and Cy (200 mg/kg) (Bu/Cy4) have more recently been employed. At least three studies of Bu/Cy2 or Bu/Cy4 have given encouraging results. Two ongoing randomized studies of Bu/Cy2 versus Cy2/TBI have shown no difference in the event free survival (EFS). In addition, two ongoing randomized studies of Bu/Cy4 versus Cy (200 mg/kg) plus TBI (Cy4/TBI) show no significant differences in EFS. It appears that Bu/Cy regimens are as effective as Cy/TBI regimens. The choice of one regimen over the other depends on matters other than therapeutic efficacy.

Adolescent↗

PubMed2001

Fludarabine in combination with cyclophosphamide or with cyclophosphamide plus mitoxantrone for relapsed or refractory low-grade non-Hodgkin's lymphoma.

BACKGROUND AND OBJECTIVES: We report the activity of two combinations of fludarabine (FLU), one with cyclophosphamide (FLU/CY) and the second with CY plus mitoxantrone (FLU/CY/MITO). The aim of the study was to evaluate the activity and toxicity of these two schedules in patients with non-Hodgkin's lymphoma (NHL). DESIGN AND METHODS: Twenty-two patients with recurrent low grade non-Hodgkin's lymphoma (LGL) received FLU/CY (FLU 25 mg/m(2) days 1 to 3, CY 300 mg/m(2) days 1 to 3), and 31 patients received FLU/CY/MITO (FLU 25 mg/m(2) days 1 to 3, CY 300 mg/m(2) days 1 to 3, mitoxantrone 10 mg/m(2) day 1). Patients received antibiotic oral prophylaxis during all treatments and growth factors (G-CSF) when grade III granulocytopenia (WHO scale) occurred. RESULTS: Of the 53 patients, 31 achieved complete remission (CR) (58%) and 16 partial remission (PR) (30%). Response was similar in both arms of the study. After 3 courses, 77% of patients who achieved CR showed a complete disappearance of disease. Seventy-nine per cent of patients experienced granulocytopenia. Few patients had fever, all without infection. One patient died with fever of unknown origin three months after completion of six courses of treatment. INTERPRETATION AND CONCLUSIONS: Both treatments were seen to be effective in recurrent low-grade NHL. Antibiotic prophylaxis with G-CSF support seems to reduce treatment-related infection.

Adult↗

PubMed2003

[Middle-high dose of cyclophosphamide or conventional routine chemotherapy with increased dose of cyclophosphamide combined with G-CSF for mobilizing peripheral blood progenitor cells in patients with tumor].

OBJECTIVE: To investigate the clinical value of glycosylated G-CSF combined with middle-high dose cyclophosphamide (Cy) or conventional chemotherapy with increased dose of Cy for mobilizing peripheral blood progenitor cells in patients with tumor. METHODS: Thirty patients from four hospitals in Beijing region were enrolled in this clinical study. Diagnoses of the patients were non-Hodgkin' lymphoma (n = 21), Hodgkin disease (n = 1), breast cancer (n = 7) and ovary cancer (n = 1). Autologous peripheral blood progenitor cells (APBPC) were mobilized by middle-high dose Cy or conventional chemotherapy with increased dose of Cy combined with G-CSF. G-CSF was given subcutaneously from the nadir of the white blood cell (WBC) count to the end of PBPC collection. The dosage of G-CSF was 250 microg/d in 29 patients and 500 microg/d in 1 patient. When WBC count was > 5 x 10(9)/L, APBPC were harvested with CS 3000 plus/COBE Spectra. RESULTS: The average dosage of Cy was 3.95 g (2.3 g/m(2)). The doses of G-CSF were 3.1 approximately 6.4 microg x kg(-1) x d(-1). Thirteen patients (43%) were collected twice, 14 patients (47%) three times and 3 patients (10%) four times. All of the patients could tolerate the treatment regimens. Seven patients had bone pain after G-CSF injection and one was severe, one patient had headache and one had nausea and vomiting. CONCLUSION: 250 microg glycosylated G-CSF combined with middle-high Cy or conventional chemotherapy with increased dose of Cy combined G-CSF is an optimal method for APBPC mobilization in tumor patients.

Adolescent↗

PubMed1976

Comparative pharmacologic study in vitro and in vivo with cyclophosphamide (NSC-26271), cyclophosphamide metabolites, and plain nitrogen mustard compounds.

This paper deals with the problem of the relative selectivity of the antitumor effect of cyclophosphamide (CP). CP and its metabolites are pharmacologically characterized by determining their chemical and biological activities in vitro and their pharmacotherapeutic properties in vivo. Of particular importance is the specificity of the cytotoxic activity (cytostatic units/mumol) in vitro and the margin of safety (therapeutic index) in vivo. The pharmacologic data reveal: a. Of the various metabolites of CP only 4-hydroxycyclophosphamide, the primary activation product, exerts a highly specific cytotoxic activity in vitro and has a wide margin of safety in vivo. b. The decisive step in toxication is the formation of the alkylating N,N-bis(2-chloroethyl)phosphorodiamidic acid after acrolein has been split off.

Acrolein↗

PubMed1976

Qualitative and quantitative investigations of cyclophosphamide (NSC-26271), cyclophosphamide metabolites, and related compounds by field-desorption mass spectrometry.

The potential of field-desorption mass spectrometry (FD-MS) coupled with photoplate detection for qualitative and quantitative studies on cyclophosphamide (CP) and its metabolites is reviewed. The characteristic features of this ionization mode are minimal fragmentation of the molecular ion coupled with the capacity to produce such ions from thermally unstable or nonvolatile samples. Since CP is itself extensively fragmented in the electron-impact ionization mode, and since it possesses both thermally unstable (eg, 4-hydroxycyclophosphamide, carboxyphosphamide) as well as ionic and hence nonvolatile metabolites (eg, phosphorodiamidic acid), the FD technique has potential value for the detection and quantitation of the drug and its metabolites in underviatized mixtures. Some of the factors which influence the reproducibility of FD spectra are enumerated. In order to improve the FD technique for quantitative results a device for emission-controlled FD was constructed and its use is described. Three different modes of operation are discussed using the FD spectra of CP conjugates typical for each. Preliminary investigations into the use of the d6 analog of CP for quantitation of the drug by FD-MS are also reported.

Chemical Phenomena↗

PubMed1991

Fluorouracil, doxorubicin, and cyclophosphamide versus fluorouracil, doxorubicin, and cyclophosphamide plus lonidamine for the treatment of advanced breast cancer: a multicentric randomized clinical study.

Experimental models have demonstrated the Adriamycin (doxorubicin; Adria Laboratories, Columbus, OH)-potentiating activity of lonidamine. Phase II clinical trials on advanced breast cancer have shown that this drug induced a 16% objective response rate. Present multicentric randomized trial was conducted to verify whether lonidamine can potentiate the antineoplastic effects of conventional fluorouacil, Adriamycin, cyclophosphamide (FAC) chemotherapy in advanced breast cancer. From January 1987 to December 1989, 265 patients were enrolled in this study, and 231 are evaluable for response. After stratification according to institution and ECOG performance status (PS), the patients were randomly allocated to receive either standard FAC therapy (group A) or FAC plus lonidamine (600 mg orally daily three times a day) (group B). After three FAC courses, the patients with no progressive disease were further randomized to either receive continuous treatment up to the time of tumor progression (maximum: 10 courses) or to discontinue therapy when a response "plateau" was reached. In this latter group, the same therapy was restarted at relapse or disease progression. Objective response (complete response plus partial response) was significantly higher in group B (66.3%) compared to group A (42.3%). The actuarial median times to disease progression was also significantly longer (P less than 0.0001) in group B (median 9 months) than in group A (median 6 months). Other than myalgia and gastric pain, no increased toxicity was observed in the lonidamine. The analysis of second randomization are yet available because of the longer follow-up time required. Present findings suggest an interesting additive effect of lonidamine when combined with FAC chemotherapy and warrant further investigation in other therapeutic regimens and in other neoplastic diseases.

Adult↗

PubMed1990

Randomized comparison of cyclophosphamide, doxorubicin and cisplatin (CAP) versus cyclophosphamide and doxorubicin (CA) for the treatment of advanced ovarian cancer (ADOVCA). A EORTC Gynecological Cancer Cooperative Group Study.

The possible advantage of adding cisplatin (P) to cyclophosphamide (C) + adriamycin (A) in the management of stages III and IV ovarian cancer of epithelial origin was tested in a trial in which 149 patients were randomized to receive, after initial surgery, either CAP (C = 600 mg/sqm, A = 45 mg/sqm, P = 50 mg/sqm) or CA (C = 600 mg/sqm, A = 45 mg/sqm) every 4 weeks for 6 to 12 cycles, at which time follow-up laparotomoy was to be performed in responding or clinically disease-free patients. Fifteen patients were not included in the final analysis and the remaining 134 patients were considered fully or partially evaluable and are used in analysis of response and survival. The complete and partial response rates were 45.6% in the CAP arm and 45.4% in the CA arm, but the CAP regimen is of special importance in patients with bulky disease. Median survival CAP = 24 m and CA = 24.2 m), time to progression and survival was found not significantly different when CAP and CA were compared. However, more patients in the CA regimen had no macroscopic disease left after surgery than in CAP regimen (11 versus 6) and more patients in the CAP arm dose reductions and schedule delays than in the CA arm (61.1% versus 38.2%).

Antineoplastic Combined Chemotherapy Protocols↗

PubMed1989

Cyclophosphamide-induced immunologically mediated regression of a cyclophosphamide-resistant murine tumor: a consequence of eliminating precursor L3T4+ suppressor T-cells.

It was shown that it is possible to use cyclophosphamide (Cy) to cause immunologically mediated regression of the immunogenic, Cy-resistant L5178Y lymphoma in syngeneic and semisyngeneic mice. In order to cause tumor regression it was necessary to give Cy shortly before or shortly after tumor implantation. However, regardless of whether Cy was given before or after tumor implantation, tumor regression did not commence until 10 days of progressive tumor growth, by which time the tumor was 1 cm in diameter. Tumor regression was associated with the presence in the spleen of an increased number of Lyt-2+ T-cells capable of passively transferring immunity to tumor-bearing recipients. This augmented level of immunity was sustained throughout the period of tumor regression. In contrast, a lower level of concomitant immunity generated by control tumor bearers decayed after Day 12 of tumor growth. Because the therapeutic effect of Cy could be inhibited by passive transfer of L3T4+ T-cells from normal donor mice it is apparent that the therapeutic effect of Cy is based on its ability to preferentially destroy L3T4+ suppressor T-cells. These putative precursor suppressor T-cells were regenerated 4 days after being destroyed by Cy. Taken together the results represent a striking example of the negative regulatory influence of suppressor T-cells on the immune response to an immunogenic tumor.

Animals↗

PubMed1985

Clinical controlled trial in advanced breast cancer: CMF (cyclophosphamide, methotrexate, 5-fluorouracil) versus CMF + T (cyclophosphamide, methotrexate, 5-fluorouracil, tamoxifen). CMEA Cooperative Treatment Group.

A controlled study with two arms was performed in 153 evaluable patients with advanced breast cancer. All patients were postmenopausal and untreated. The first combination included cyclophosphamide, methotrexate, 5-fluorouracil (CMF, 82 patients) while the second one contained the same cytostatic combination and tamoxifen (zitazonium) (CMF + T, 71 patients). Patients were prospectively stratified according to the dominant sites of metastases and randomized to the respective treatment schedule. In CMF combination the response rate (CR + PR) was 33/82 (40%) and complete response (CR) 8/82 (10%), respectively. In the CMF + T arm the corresponding values were 29/71 (41%) and 14/71 (20%), respectively. From the analysis of the data the superiority of the CMF + T arm could be established concerning CR in soft tissue and CR + PR in bone localization.

Adult↗

PubMed1986

Doxorubicin, cyclophosphamide, etoposide and platinum, doxorubicin, cyclophosphamide and etoposide for small-cell carcinoma of the lung.

Small-cell lung cancer (SCLC) is a disseminated disease regardless of our ability to document all sites. Chemotherapy is thus the cornerstone of treatment. There are multiple active single agents, resulting in many combination chemotherapy regimens. Optimal combinations are probably derived from the use of synergistic drug interactions. A three drug combination of doxorubicin (Adriamycin), cyclophosphamide, and etoposide (ACE) has been used at the University of Maryland Cancer Center (UMCC) for more than a decade in sequential studies. Two hundred four patients, 143 men and 61 women, were treated on these studies. Eighty-five had limited disease (LD) and 119 had extensive disease (ED). The complete response (CR) frequencies were 65% and 43% for LD and ED, respectively, and the median survivals were 15 and 9.5 months, respectively. Twenty-two percent of the LD patients were alive at 2 years. To improve upon response or survival, and because of synergy, cisplatin was added to ACE (PACE). PACE chemotherapy was administered in two studies--study 1 at UMCC for both LD and ED, and study 2 by Cancer and Acute Leukemia Group B (CALGB) for ED only. Preliminary review suggests that CR frequencies for LD (53%, study 1) and ED (44%, study 1; 37%, study 2) were similar to prior studies, but median survivals (LD, 18+ months, study 1; ED, 15 months, study 1, 10.5 months, study 2) appears superior to previous studies. However, PACE is more toxic than ACE. Further studies of PACE are needed to assess if the additional toxicities are warranted.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed1985

Enhancement by cyclophosphamide of experimental pulmonary metastases formation of Lewis lung carcinoma. II. Reduction of the cyclophosphamide effect by repopulation with cells from lymphoid organs.

Cyclophosphamide-induced enhancement of artificial lung metastasis of LL2 could be partly abolished by reconstituting of mice with spleen, lymph nodes or bone marrow cells but not with thymus cells. At cell dose of 10 x 10(6) per mouse the highest reconstituting capacity was found for spleen cells (73%) followed by bone marrow (60%) and lymph nodes cells (22%). Cell dose of 10(6) lymphoid cells per mouse did not reduce the CY-effect. The higher cell number (30 x 10(6) and 50 x 10(6) per mouse) did not abolish completely the CY-effect. The results indicate that in addition to sensitive lymphoid cells there exists another target for CY effect.

Animals↗

PubMed1984

A randomized trial of adriamycin, cyclophosphamide, ftorafur (ACF) and adriamycin, cyclophosphamide, ftorafur, methotrexate (ACFM) in patients with advanced breast cancer.

A prospective randomized trial was conducted comparing the clinical response of 60 patients with advanced breast cancer to a combination of adriamycin, cyclophosphamide, and oral ftorafur (ACF), or to a combination of ACF plus methotrexate (ACFM). The response rate was 12 of 28 (43%) in ACF and 18 of 30 (60%) in ACFM. Responses were seen more frequently in patients in whom fewer than two organs were involved, and responses at dominant metastatic sites were equal for the two arms. The response duration was 21 + (3.5-49.5+) months with ACF, as against 6.9 (1.9-30.8+) months with ACFM (P less than 0.05). The median survival time from start of therapy was 20.8+ months for ACF, while that for ACFM was 13+ months (statistically not significant). The major toxicities were hair loss, GI toxicity, and leukopenia. The response rate with ACFM was higher than that with ACF, but the addition of methotrexate to ACF did not increase the complete response rate or prolong response duration.

Adult↗

PubMed1984

[A randomized trial of adriamycin, cyclophosphamide, ftorafur (ACF) and adriamycin, cyclophosphamide, ftorafur, methotrexate (ACFM) in patients with advanced breast cancer].

A prospective randomized trial was conducted to compare the clinical responses of sixty patients with advanced breast cancer to a combination of adriamycin, cyclophosphamide and oral ftorafur (ACF), or to a combination of ACF plus methotrexate (ACFM). The response rate was 12/28 (43%) for ACF compared with 18/30 (60%) for ACFM. Responses were seen more frequently in the cases which had less than 2 organs involved and responses of dominant metastatic sites were equal for the two arms. The duration of response for ACF was 21+ (3.5-49.5+) months as compared to 6.9 (1.9-30.8) months for ACFM (p less than 0.05). The median survival time from the start of chemotherapy for ACF was 20.8+ months, while that for ACFM was 13+ months. The major non-hematological toxicities were hair loss and GI symptoms. Hematological toxicity was similar in the two arms and manageable. No serious cardiac, renal and liver damage was seen in either arm. The response rate for ACFM was higher than that in ACF, but the addition of methotrexate to the ACF regimen did not increase complete response and prolong response duration.

Adult↗

PubMed1978

cis-Dichlorodiammineplatinum(II) alone followed by adriamycin plus cyclophosphamide at progression versus cis-dichlorodiammineplatinum(II), adriamycin, and cyclophosphamide in combination for adenocarcinoma of the lung.

Forty-one patients with proven metastatic adenocarcinoma of the lung were randomized into two comparable groups after stratification for performance status and presence of measurable or evaluable disease. Treatment 1 consisted of cis-dichlorodiammineplatinum(II) (P) at a dose of 15 mg/m2/day by iv push on Days 1--5 every 4 weeks. Upon progression or the onset of renal toxic effects, patients were crossed over to cyclophosphamide (C) at a dose of 400 mg/m2, and adriamycin (A) at a dose of 40 mg/m2, both given by iv push on Day 1 every 4 weeks. Treatment 2 (CAP-I) consisted of C-A in the same doses as above plus concurrent P, 40 mg/m2 by IV push on Day 1 every 4 weeks. Eight patients receiving P developed serum creatinine values greater than or equal to 1.5 mg/100 ml versus one patient receiving CAP-I (P = 0.05). Objective regressions occurred in two of 22 patients with P, five of 17 with C-A, and eight of 19 with CAP-I (P = 0.025; CAP-I versus P). There was a significant increase in the median duration of regression in patients responding to C-A following P (267 days) versus patients responding to CAP-I (95 days). The improved rate of response with CAP-I and the prolonged duration of response with C-A following P suggest a potentiating effect between P and C-A whether given simultaneously or sequentially.

Adenocarcinoma↗