Assessment of the cost of first line chemotherapy in metastatic colorectal cancer. Preliminary results in the FFCD 9601 trial

AIM: The objective of the study was to estimate the cost of first line chemotherapy in metastatic colorectal cancer treated in the Gustave-Roussy Institute. Patients were randomized in the study FFCD 9601 with four schedules of treatment: Tomudex(R), 5FU weekly, LV5FU2 with low dose of folinic acid and LV5FU2 with high dose of folinic acid. PATIENTS AND METHODS: Thirty three patients were included prospectively from March 1997 to April 1999. Healthcare costs took into account drug-regimen related costs (cost of the drugs and its preparation, drug administration, laboratory tests, transport from and to hospital), non-drug-regimen related hospitalization costs (treatment of chemotherapy related side effects, radiologic tests, hospital outpatient visits, transport from and to hospital) and surgery costs. Costs were derived from the accounting system in the Gustave-Roussy Institute. Non medical costs were not taken into account in this study. RESULTS: The median overall cost per 4 weeks was 6,343 FF with LV5FU2 low dose, 9,968 FF with LV5FU2 high dose, 15,340 FF with 5FU weekly and 28,810 FF with Tomudex(R). This overcost is explained by a more expensive price and greater toxicity: 12 grade 3-4 toxicity and 9 hospitalizations (including one in intensive care unit for the 8 treated patients) for Tomudex(R) despite a lower cost for the administration of the drug. Weekly 5FU was the most expensive among the 5FU schedules because of its dose and frequency of administration. CONCLUSIONS: The cost of first line chemotherapy in metastatic cancer colorectal is high (6,000 FF minimum per 4 weeks of treatment). Tomudex, a recent and expensive drug, seems to be more toxic. In this study, toxicity was probably overestimated due to the small number of patients. More patients are necessary in order to better estimate the cost of toxicity of these chemotherapies.     

FOLFOX3 in heavily pretreated patients with metastatic colorectal cancer

BACKGROUND: The combination of oxaliplatin, 5-fluorouracil (5FU) and leucovorin (LV) has shown to be active and safe as first- or second-line chemotherapy for metastatic colorectal cancer (MCC). PATIENTS AND METHODS: The outcome of patients with MCC who had progressive disease after at least two lines of palliative chemotherapy and who were subsequently treated with oxaliplatin, 5FU and LV was reviewed. Patients received FOLFOX3 consisting of oxaliplatin (85 mg/m2) on day 1, LV (500 mg/m2) as a two-hour infusion on days 1 and 2, and 5FU (3000 mg/m2) as a 46-hour infusion starting on day 1 in a cycle of two weeks. RESULTS: A total of 28 patients were treated with a median number of 9.5 cycles (range 1-24) at a mean dose intensity of 73%. Six patients discontinued treatment due to toxicity, of whom three had sensory neuropathy grade 2. Six patients experienced grade 3 toxicity: nausea (1), vomiting (1), diarrhoea (1), leucopenia (2) and thrombocytopenia (1); grade 4 toxicity was not observed. Twenty-five patients were evaluable for response, of whom four achieved a partial response (response rate 14%, based on intention to treat). The median progression-free survival was 5.8 months and the median overall survival was 8.5 months. CONCLUSION: For heavily pretreated patients with MCC, the FOLFOX3 regimen is a fairly safe and effective treatment.     

Activity and toxicity of docetaxel (Taxotere®) in women with previously treated metastatic breast cancer

Abstract Background: Metastatic breast cancer is a major cause of cancer death in Australian women. Docetaxel is a new cytotoxic drug that has shown promise in the treatment of metastatic breast cancer in patients who have previously received other chemotherapy, particularly an anthracycline, and has recently been approved for marketing in Australia. Aim: To report the first Australian experience with docetaxel in a group of women with metastatic breast cancer. Methods: Patients with progressive metastatic breast cancer who had previously received other chemotherapy were treated with docetaxel 75 mg/m² or 100 mg/m² given as a one hour infusion every three weeks. All patients received oral dexamethasone for five days starting 24 hours prior to docetaxel as prophylaxis against fluid retention. The patients' response to docetaxel and toxicity were assessed by standard criteria. Results: Twenty-six patients were treated. The major toxicity was neutropenia with 92% of patients experiencing at least one episode of grade 4 (absolute neutrophil count <0.5X10⁹/L) neutropenia. Hospital admission for febrile neutropenia occurred in 44% of patients with one death from sepsis. Cumulative fluid retention was observed but in only one patient was it dose-limiting. Apart from alopecia, other toxicities were infrequent and rarely serious. In 23 patients assessable for response, there were 11 partial responses (48%). Three other patients whose disease could not be assessed for response had clinical improvement. The median survival of all patients treated was eight months. Conclusions: The response rate observed with docetaxel is comparable to that seen in trials in the United States and Europe and confirms the high activity of this new cytotoxic agent. Neutropenia is the major toxicity, and consideration should be given to the use of prophylactic oral antibiotics or colony stimulating factors to try and prevent febrile episodes. Clinicians will need to balance the benefits, toxicities, and cost of docetaxel in determining the appropriateness of its use in their patients.     

Phase II study of high dose epirubicin in combination with cyclophosphamide in patients with advanced breast cancer

Abstract Background: Combination chemotherapy for metastatic breast cancer will palliate symptoms in the majority of patients but only a small percentage will have prolonged survival. Higher doses of doxorubicin lead to increased response rates in breast cancer and early studies have shown that epirubicin could be tolerated in higher doses with less relative toxicity than doxorubicin. Aims: This study was initiated to assess the dose of epirubicin that could be tolerated by escalating its dose while maintaining a fixed dose of cyclophosphamide. Simultaneously tumour response rate, spectrum of toxicities, duration of response and overall survival in patients with metastatic breast cancer were assessed. Methods: Patients with metastatic breast cancer commenced chemotherapy with a starting dose of epirubicin of 120 milligram per metre squared (mg/m²) and cyclophosphamide 600 mg/m². The dose of epirubicin was to be escalated or reduced depending on toxicity. Results: Forty female patients were entered into this study and three patients withdrew because of toxicity. Overall tumour response rate was 75% with 27.5% of patients obtaining a complete response. Median time to progressive disease was 35 weeks and median overall survival was 48 weeks, with median survival for complete responders being 103 weeks. Thirty-one (77%) patients completed five or more courses of treatment. Haematological toxicity was the main side effect and 70% of patients required a dose reduction. No patients were eligible for a dose escalation. One patient died as a consequence of neutropenic sepsis. Four (10%) patients had treatment ceased because of decrease in left ventricular ejection fraction and one patient died as a consequence of heart failure. Four patients remain alive. Conclusions: High dose epirubicin combined with cyclophosphamide is an effective treatment regimen for metastatic breast cancer obtaining higher overall response rates with increased percentage complete responses compared to conventional dose chemotherapy. Although toxicity was increased, high dose chemotherapy was well tolerated and mortality associated with treatment was not increased. No dose escalations of epirubicin were possible and a dose of 90mg/m² of epirubicin would be the maximum dose when used in combination with cyclophosphamide. Further trials are required to determine the influence of this high dose therapy on survival duration and whether comparable benefits can be achieved with shorter durations of therapy. (Aust NZ J Med 1995; 25: 474–478.)     

Gemcitabine as prolonged infusion and vinorelbine in anthracycline and/or taxane pretreated metastatic breast cancer: a phase II study

Background: Gemcitabine and vinorelbine are active agents for the treatment of metastatic breast cancer. Prolonged infusion of gemcitabine can result in higher levels of active metabolites compared to shorter administration. This phase II trial was initiated to evaluate the efficacy and tolerability of gemcitabine as prolonged infusion in combination with vinorelbine in anthracycline and/or taxane pretreated patients with metastatic breast cancer. Patients and methods: Patients who had received one prior line of chemotherapy for metastatic disease were treated with gemcitabine (350 mg/m² as 4 h infusion) and vinorelbine (25 mg/m²) on days 1 and 8. Treatment was repeated every 3 weeks for a maximum of six cycles. Results: Of 26 patients enrolled, 84% had received prior anthracycline treatment and 50% prior taxane therapy. In total, one complete and six partial responses were achieved, accounting for an overall response rate of 30.4%. The clinical benefit rate was 47.8%. Median duration of response and median time to progression were 7.3 months and 4.6 months, respectively. Median overall survival was 14.5 months. Although the predominant toxicity was myelosuppression with grade 3/4 neutropenia in 42% of patients, few neutropenic complications resulted. Non-hematological toxicity was generally moderate. Most common non-hematologic toxicities were nausea, vomiting, alopecia, peripheral neuropathy and elevation of liver enzymes. Conclusion: Gemcitabine as prolonged infusion and vinorelbine are a safe and effective combination treatment in anthracycline and/or taxane pretreated patients. Approximately 47.8% of patients derived clinical benefit from treatment. This regimen represents a therapeutic option for patients receiving second-line therapy for metastatic breast cancer.     

Analysis of pathological complete response rates with paclitaxel‐based regimens in trimodality therapy for esophageal cancer

The study aimed to examine whether omission of 5‐fluorouracil (5‐FU)‐containing chemotherapy alters pathological complete response rates in patients receiving trimodality therapy for locally advanced esophageal cancer. A total of 159 patients were identified. One hundred twenty‐nine patients received platinum/5‐FU concurrently with radiotherapy, and 30 received taxane/platinum‐containing chemoradiotherapy prior to esophagectomy. Patients were staged using the 2002 American Joint Committee on Cancer staging system. Patients were matched between chemotherapeutic groups, with no significant demographic or clinical differences other than T stage (14% T2 in the 5‐FU group; no T2 in the platinum/taxane group) and radiotherapy technique (8.5% received intensity‐modulated radiotherapy in the 5‐FU group; 60% in the platinum/taxane group). Pathological complete response rates for 5‐FU and platinum/taxane‐based groups were not significantly different (45% and 30%, respectively; P = 0.1548). Five‐year overall survival and progression‐free survival were not statistically different between the two groups. Significant predictors of pathological complete response included N stage (56% N0 and 33% N1; P = 0.0083), histology (37% adenocarcinoma and 59% squamous cell; P = 0.0123), tumor location (39% distal and 59% proximal/mid; P = 0.048), gastroesophageal junction involvement (33% involved and 55% uninvolved; P = 0.005), and radiotherapy end‐to‐surgery interval (50% < 55 days and 34% ≥ 55 days; P = 0.04). Grades 3–4 hematological toxicity was higher in the 5‐FU group (36%) than in the paclitaxel‐containing therapy group (17%; P = 0.0484). Use of paclitaxel‐containing chemoradiotherapy did not result in inferior pathological complete response, overall survival, or progression‐free survival rates, and resulted in less hematological toxicity than 5‐FU treatment.     

Postoperative chemoradiotherapy after surgical resection of gastric adenocarcinoma: can LV5FU2 reduce the toxic effects of the MacDonald regimen?: A report on 23 patients

AIM OF THE STUDY: A North American phase III trial has recently shown that postoperative chemoradiotherapy using the FUFOL Mayo Clinic regimen improves overall survival and relapse-free survival after surgical resection of gastric cancer. However, severe grade 3-4, hematologic and gastrointestinal toxicities were frequent. The aim of this retrospective and multicentric study was to determine the tolerance of a postoperative chemoradiotherapy regimen using LV5FU2 instead of the Mayo Clinic regimen. PATIENTS AND METHODS: Twenty-three patients with resected adenocarcinoma of the stomach or gastroesophageal junction at high risk of recurrence were treated with LV5FU2 chemotherapy and radiotherapy (45 Gy in 25 fractions and 5 weeks) delivered to the tumor bed and regional nodes. Nineteen patients were treated with two to four cycles before radiotherapy, then three cycles during radiotherapy, and finally four cycles after radiotherapy; four patients were only given three cycles during radiotherapy. RESULTS: Of the 23 patients assigned to this protocol, 20 completed treatment (87%). There was only one interruption of treatment because of hematologic or gastrointestinal toxicity. Tolerance of LV5FU2 regimen associated with radiotherapy was excellent: one grade 3 or 4 gastrointestinal toxicity (4.3%), no toxic death, and only one grade 3 neutropenia (4.3%) were reported. CONCLUSION: Radiotherapy combined with LV5FU2 appears to be better tolerated than the Mayo Clinic regimen used in the North American study. These results have to be considered when elaborating future postoperative chemoradiotherapy trials for gastric cancer.     

First-line chemotherapy with fluorouracil and folinic acid for advanced colorectal cancer in elderly patients: a phase II study

BACKGROUND: Colorectal cancer is one of the most common cancers in the elderly. Information on tolerability and efficacy of 5-Fluorouracil-based chemotherapy in such patients is limited. Primary aim of the study was to describe tolerability and activity of chemotherapy with the "de Gramont" schedule (FU bolus [400 mg/m ] + FU continuous infusion [600 mg/m ] + folinic acid [100 mg/m ] on days 1 and 2, every 2 weeks), in patients with advanced colorectal cancer aged 70 or older. PATIENTS AND METHODS: Patients aged 70 or more, with stage IV colorectal cancer, ECOG performance status not worse than 2. RESULTS: Thirty-four patients were treated at two participating centers. Seven (20.6%, 95% exact CI = 8.7-37.9) had an objective response, complete in 3 and partial in 4 patients. Five cases of unacceptable toxicity were registered (2 cardiac, 1 each for liver, anemia and diarrhea). Fitting the statistical model to the observed data indicated that the treatment was sufficiently active and tolerated. CONCLUSIONS: The de Gramont scheme is active and tolerated in elderly patients with advanced colorectal cancer.     

5-Fluorouracil plus interferon α-2a compared to 5-fluorouracil alone in the treatment of advanced colon carcinoma: A multicentric randomized study

Biochemical modulation is one of the most interesting fields in cancer chemotherapy. Interferon-α (IFNα) is a cytokine that is able to influence the pharmacodynamics of 5-fluorouracil (5FU) through a number of mechanisms. With the aim of confirming some data emerging from the literature, we initiated a multicentric randomized study comparing the combination of 5FU and IFNα-2a with 5FU alone in the treatment of advanced or metastatic colon cancer. A group of 205 colon cancer patients (104 in the 5FU arm and 101 in the 5FU+IFNα-2a arm) were included in the final intention-to-treat analysis. Rectal cancers were not considered eligible. All patients had measurable disease, were aged 75 years or less, had a Karnofsky index of at least 60 and had good bone marrow, renal, liver and cardiac functions. No previous chemo-immunotherapy was allowed. The treatment was 750 mg/m² 5FU (4 h i.v. infusion) on days 1–5 and then i.v. bolus weekly, starting from day 12, with or without IFNα-2a given s.c. three times weekly (starting dose 3 × 10⁶ IU rising to 9 × 10⁶ IU, if tolerated). Patients were treated until progression or, if responsive, for a maximum of 48 weeks and then observed for a period of 2 years. The primary end-point of the study was objective clinical response (OR); secondary parameters were time to progression, overall survival, and time to death after progression. WHO criteria were used for both clinical response and toxicity measurements. Dose reduction was planned a priori in the event of significant toxicity due to 5FU, IFNα-2a or both. Association between primary and secondary end-points and treatment was studied by univariate and multivariate analysis. Altogether, 47 patients achieved a documented response. A 25% OR was observed in the combination arm while a 21% OR was seen in the 5FU arm; this difference is not statistically significant (P=0.6). Patients with a small tumour burden (below 5 cm²) showed a higher probability of response in both arms. Patients in the experimental arm had a higher but not statistically significant cumulative progression-free probability. Median survival was 47.1 weeks overall, while it was 43.7 and 48.5 weeks in the control and experimental arms, respectively. The combination was clearly more toxic than 5FU alone, leukopenia being the most frequent side-effect in the experimental arm and nausea and vomiting in the control arm. In conclusion these results are quite disappointing and 5FU + IFNα-2a can not be considered a standard treatment for advanced colon cancer. Received: 12 February 1997 / Accepted: 17 November 1997     

5-Fluorouracil (5FU) treatment does not influence invasion and metastasis in microsatellite unstable (MSI-H) colorectal cancer

Microsatellite instability is a recognised pathway of colorectal carcinogenesis responsible for about 15% of all sporadic colorectal cancers. Recent evidence has suggested that these tumours may not have the same response as microsatellite stable colon cancers to 5-fluorouracil (5FU)-based chemotherapy. The response to 5FU in four microsatellite unstable (MSI-H) cell lines was examined by cell viability assays and invasion assays. Flow cytometry was used to assess the effect of 5FU on MSI-H cell lines. In vivo response to 5FU was assessed by intraperitoneal injection of 5FU or control to 80 nude mice that had received intrasplenic injections of an MSI-H cell line KM12C prior to commencing treatment. There was inhibition of cell growth in MSI-H cell lines when treated with 5FU. There was no difference in invasiveness in the MSI-H cell lines when treated with 5FU. Primary tumours formed in 27 of the untreated and 25 of the 5FU treated mice (p=NS). There was a 36% reduction in splenic weight in those mice treated with 5FU (p<0.03). Metastases formed in 5 of the untreated and 9 of the treated mice (p=0.12). 5FU treatment of MSI-H tumours results in a reduction in growth but does not result in a reduction in invasion or metastasis.     

A clinical trial to evaluate the worth of preoperative multimodality therapy in patients with operable carcinoma of the rectum

PURPOSE: National Surgical Adjuvant Breast and Bowel Project Protocol R-03 was designed to determine the worth of preoperative chemotherapy and radiation therapy in the management of operable rectal cancer. METHODS: Thus far, 116 patients of an eventual 900 with primary operable rectal cancer have been randomized to receive multimodality therapy to begin preoperatively (59 patients) or identical therapy beginning after curative surgery (57). All patients received seven cycles of 5-fluorouracil (FU)/leucovorin (LV) chemotherapy. Cycles 1 and 4 through 7 used a high-dose weekly FU regimen. In Cycles 2 and 3, FU and low-dose LV chemotherapy was given during the first and fifth week of radiation therapy (5,040 cGy). The preoperative arm (Group 1) received the first three cycles of chemotherapy and all radiation therapy before surgery. The postoperative arm (Group 2) received all radiation and chemotherapy after surgery. Primary study end points included disease-free survival and survival. Secondary end points included local recurrence, primary tumor response to combination therapy, tumor downstaging, and sphincter preservation. RESULTS: Overall treatment-related toxicity was similar in both groups. Although seven preoperative patients had events after randomization that precluded surgery, eight events occurred during an equivalent follow-up period in the postoperative group. No patient was deemed inoperable because of progressive local disease. Sphincter-saving surgery was intended in 31 percent of Group 1 patients and 33 percent of Group 2 patients at the time of randomization. Such surgery was actually performed in 50 percent of the preoperatively treated patients and 33 percent of the postoperatively treated patients. The use of protective colostomy in patients undergoing sphincter-sparing surgery and the development of perioperative complications in all surgical patients were similar in both groups. There was evidence of tumor downstaging in evaluable patients under-going preoperative therapy, with 8 percent of Group 1 patients having had a pathologic complete response. CONCLUSION: These data do suggest that the preoperative chemotherapy and radiation therapy regimen used are, at least, as safe and tolerable as standard postoperative treatment. There is presently a trend to tumor downstaging and sphincter preservation in the preoperative arm. Whether this arm will have greater or lesser survival and long-term toxicity awaits the completion of this relevant study.Supported by National Cancer Institute Grants U10-CA-12027 and U10-CA-37377 and American Cancer Society Grant R-13.Read at the meeting of The American Society of Colon and Rectal Surgeons, Seattle, Washington, June 9 to 14, 1996.     

Australasian multicentre phase II study of paclitaxel (Taxol*) in relapsed ovarian cancer

Background: Until recently there has been no effective therapy for patients with relapsed ovarian carcinoma following standard platinum based chemotherapy. Paclitaxel has recently been approved for clinical use in this malignancy. Aims: To evaluate the objective response rate and toxicity of paclitaxel in patients with relapsed ovarian cancer. Methods: Paclitaxel was given on an outpatient basis as a three hour infusion every 21 days for a maximum often cycles to 72 patients with advanced ovarian cancer previously treated with at least one platinum containing regimen. The starting dose was either 175 mg/m² (patients with one or two prior chemotherapy regimens) or 135 mg/m² (three previous regimens). Premedication was given because of the documented risk of hypersensitivity reactions to paclitaxel. Results: The overall response rate was 22% (95% confidence interval [CI] 13% to 34%) in the 72 patients enrolled in the study: four patients had a complete response. Three patients (4%) ceased treatment due to hypersensitivity reactions. Other significant (WHO grade 3 or 4) toxicities included neutropenia (51%), myalgia (14%), neurological (3%), alopecia (93%) and nausea and vomiting (3%). The estimated median survival of all patients was 9.8 months (95% CI: 9.1–13.0 months) with 44% alive at one year (standard error [SE] 7%). Conclusions: This study confirms that paclitaxel given as a three hour infusion has significant activity and acceptable toxicity in advanced ovarian carcinoma previously treated with platinum regimens.     

A new combination chemotherapy with cis-diammine-glycolatoplatinum (Nedaplatin) and 5-fluorouracil for advanced esophageal cancers

OBJECTIVE: The efficacy of a new chemotherapeutic combination consisting of Cis-diammineglycolatoplatinum (Nedaplatin), a derivative of cisplatin (CDDP), and 5-fluorouracil (5FU) was evaluated in patients with advanced esophageal carcinomas. METHODS: Nedaplatin was administered at a dose of 80 or 100 mg/m2 with 500 ml of saline by slow drip infusion for 120 minutes on day 1. 5FU at a dose of 350 or 500 mg/m2 was mixed with 1,000 ml of saline and administered by continuous infusion for 24 hours on days 1 to 5. PATIENTS OR MATERIALS: This combination chemotherapy was tried in 17 patients with metastatic, recurrent, or bulky unresectable esophageal cancers. Of these, 15 evaluable patients received at least two courses of chemotherapy. RESULTS: The response rates in assessable and all patients were 60% and 52.9%, respectively. Cases with lymph node and liver metastases, as well as primary lesions, showed excellent response to the therapy with positive response rates of 54.5% (6/11), 100% (5/5) and 58.4% (7/12), respectively. The median response duration was 7 (range 3 to 37+) months for patients who achieved a partial response. Adverse drug reactions were limited to three cases of grade 3 toxicity, including allergy, and decreased hemoglobin and platelets, which were well tolerated by the patients. CONCLUSION: The present study thus indicated the combination chemotherapy of Nedaplatin and 5FU to be safe and efficacious for advanced esophageal cancer. Further investigations are clearly warranted.     

Epirubicin, cyclophosphamide and weekly paclitaxel as neoadjuvant chemotherapy for stage II and III breast cancer

Purpose: To assess the efficacy and the toxicity of a new combination of epirubicin, cyclophosphamide and paclitaxel as neoadjuvant chemotherapy for breast cancer. Methods: Patients with stage II and III breast cancer received 3–4 cycles of epirubicin 75 mg/m² plus cyclophosphamide 600 mg/m² on day 1, and paclitaxel at a dose of 100 mg on days 1, 8, 15 and 22 on a 28-day cycle. Results: Forty-nine patients were enrolled in the study. Stage II was present in 16 patients (32.7%) and stage III in 33 patients (67.3%). Relevant toxicities were nausea/vomiting grades III–IV in 6 patients (12.2%) and neutropenia grade III–IV in 33 patients (67.3%). The overall clinical response rate was 83.7%. Partial response was observed in 25 patients (51%), complete response in 16 patients (32.7%), stable disease in 7 patients (14.3%) and progression in 1 patient. Thirty-three non-inflammatory breast cancer patients underwent surgery, 29 with breast-conserving surgery (87.9%). Pathological complete response was found in 5 patients (15.1%). Conclusions: The combination of epirubicin, cyclophosphamide and weekly paclitaxel as given in this study is safe and shows good activity in the neoadjuvant setting of stage II and III breast cancer patients.     

Emergency department presentations in early stage breast cancer patients receiving adjuvant and neoadjuvant chemotherapy

(Neo)adjuvant chemotherapy for early stage breast cancer is associated with side‐effects, resulting in increased emergency department (ED) presentations. Treatment‐related toxicity can affect quality of life, compromise chemotherapy delivery and treatment outcomes, and increase healthcare use. We performed a retrospective study of ED presentations in patients receiving curative chemotherapy for early breast cancer to identify factors contributing to ED presentations. Of 102 patients, 39 (38%) presented to ED within 30 days of chemotherapy, resulting in 63 ED presentations in total. Most common reasons were non‐neutropenic fever (17 presentations/27%), neutropenic fever (15/24%), pain (9/14%), drug reaction (6/10%) and infection (4/6%). Factors significantly associated with ED presentation were adjuvant chemotherapy timing compared to neoadjuvant timing (P = 0.031), prophylactic antibiotics (P = 0.045) and docetaxel‐containing regimen (P = 0.018).     

Continuous 5-day infusion of vinblastine for percutaneous hepatic arterial chemotherapy for metastatic breast cancer

We assessed the therapeutic efficacy and toxicity of continuous hepatic infusion of vinblastine in the treatment of breast cancer predominantly metastatic to the liver. Twenty-six patients previously treated with one or more chemotherapeutic regimens received vinblastine at a dose of 2.0 mg/m2 daily for 5 days, via percutaneously inserted intra-arterial catheters, at 3-4-week intervals. Nine of 25 evaluable patients (36%) achieved partial response and four (16%) had minor response. For responding patients, the median time to disease progression was 21 weeks (range, 12-99), with a median survival of 11 months (range, 4-29) from the beginning of hepatic arterial infusion. The toxicity of the treatment was acceptable, and drug-related effects were comparable to those seen in patients with breast cancer treated by iv continuous infusion of vinblastine at slightly lower doses. We observed two episodes of transient inappropriate antidiuretic hormone secretion. Percutaneous hepatic arterial infusion of vinblastine had significant activity in the treatment of breast cancer metastatic to the liver.     

Incidence of febrile neutropenia and neutropenic infections in elderly patients receiving anthracycline-based chemotherapy for breast cancer without primary prophylaxis with colony-stimulating factors

There is concern about the potential increase of hematological toxicity in elderly patients treated with chemotherapy. Recently, primary prophylaxis with colony-stimulating factors (CSFs) was proposed for elderly patients receiving moderately toxic chemotherapy. However, evidence for the benefits of this primary prophylaxis for elderly breast cancer patients is currently lacking. We retrospectively analyzed the incidence of febrile neutropenia (FN) and neutropenic infections in elderly breast cancer patients receiving anthracycline-based chemotherapy without primary prophylaxis with colony-stimulating factors. In addition, we assessed the direct costs of hospitalization for these complications. Febrile neutropenia or neutropenic infection occurred in 13% of the 46 patients. Further studies are needed to adequately evaluate the risk of neutropenic complications (NC) in elderly patients receiving standard-dose chemotherapy for breast cancer and the potential benefits of primary prophylaxis with colony-stimulating factors.     

A Phase II trial of the combination of vinorelbine and capecitabine as second-line treatment in metastatic breast cancer previously treated with taxanes and/or anthracyclines

Purpose  

Survival time for metastatic breast cancer (MBC) can be substantially improved by combination chemotherapy in the adjuvant setting. Capecitabine and vinorelbine have shown considerable efficacy and favourable toxicity as single agents. The aim of this study is to evaluate the response to the combination of capecitabine and vinorelbine as second-line treatment in patients previously treated with taxanes and/or anthracyclines.     

羟基喜树碱为主治疗原发性肝癌临床疗效观察

目的：观察羟基喜树碱（HCPT）为主治疗原发性中晚期肝癌（HCC）的疗效和毒副作用。方法：采用HCPT加5－氟尿嘧啶（5－FU）加CF联合治疗方案治疗中晚期HCC36例（治疗组）,并与单纯5－FU加CF治疗HCC13例（对照组）进行比较。结果：治疗组患者临床症状缓解,有效率为72．2％（22／36）,毒副反应发生率低,平均生存期为7．4个月。对照组有效率61．5％（8／13）,平均生存期为5．8个月。结论：以HCPT联合化疗方案治疗中晚期HCC,有可能延长患者生存期,提高生存质量,值得进一步研究。     

内镜电化学(5-FU)治疗中晚期食管癌

目的 探讨内镜电化学加局部化疗对中晚期食管癌的治疗作用。 方法 采用内镜电化学加食管癌肿局部注射5-FU治疗16例中病例确诊的晚期食管癌。 结果 治疗后达CR 6例,PR 8例,NC 2例。总有效率(CR PR)87.5％(14/16)。无明显毒副作用。 结论 内镜电化学治疗加局部化疗对严重吞咽困难失去手术时机的中晚期食管癌有较好的治疗作用。