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  • 1
    Electronic Resource
    Electronic Resource
    Phase II study of vindesine in disseminated squamous cell carcinoma of the uterine cervix: an EORTC Gynecological cancer Cooperative Group study (1991)
    Oxford, UK : Blackwell Publishing Ltd
    International journal of gynecological cancer 1 (1991), S. 0 
    Details
    ISSN: 1525-1438
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: Abstract. Vermorken JB, Landoni F, Pecorelli S, Piccart MJ, van derBurg MEL, ten Bokkel Huinink WW, George M, Greggi S, Rotmensz N. Phase II study of vindesine in disseminated squamous cell carcinoma of the uterine cervix: an EORTC Gynecological Cancer Cooperative Group study. Int J Gynecol Cancer 1991; 1: 248–252.Twenty-nine patients with disseminated squamous cell carcinoma of the uterine cervix were treated with a 3 mg/m2 weekly i.v. bolus schedule of vindesine for 6 weeks (thereafter every 2 weeks). Twenty-seven patients were evaluable for response, 19 of whom had received prior chemotherapy (14 also vincristine). Five of the 27 patients (19%) showed a partial response, all being part of the 22 patients with only distant metastases. No objective response were observed among five patients who also had loco-regional recurrent disease. The median duration of response was 21 (11–58) weeks. Dose-limiting toxic effects were leukopenia and peripheral neuropathy. Vindesine warrants further study in combination chemotherapy protocols for cervical cancer.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1111/j.1525-1438.1991.tb00050.x
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  • 2
    Electronic Resource
    Electronic Resource
    Pitfalls in grading severity of chemotherapy-induced peripheral neuropathy (1998)
    Springer
    Annals of oncology 9 (1998), S. 739-744 
    Details
    ISSN: 1569-8041
    Keywords: chemotherapy ; grading ; peripheral neurotoxicity
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background: Reliable reporting of chemotherapy-induced neurotoxicity is important. The objectives of the current study were to evaluate the differences in the peripheral neurotoxicity sections of several widely used chemotherapy-related toxicity grading systems, and the differences in the way in which observers interpret these scales. Patients and methods: Two neurologists independently rated the severity of chemotherapy-induced peripheral neuropathy, according to WHO, ECOG, Ajani, and NCIC-CTC criteria in 37 patients. Results: The highest percentage grade 1, grade 2 and grade 3 peripheral neurotoxicity was noted when employing the WHO, Ajani and NCIC-CTC scales, respectively. Percentage interobserver agreement across all grades of severity ranged from 45.9 (NCIC-CTC) to 83.8 (WHO). The degree of agreement varied from ‘poor to fair’ to ‘substantial’. Percentage interobserver agreement for the dichotomy grade ≤2 and grade 3 ranged from 81.1 (NCIC-CTC) to 94.6 (Ajani and WHO), however, exact agreement on grade 3 peripheral neurotoxicity ranged from 0 (Ajani and WHO) to 42% (NCIC-CTC). Percentage interscale agreement for the dichotomy grade ≤2 and grade 3 varied from 67.6 (WHO and NCIC-CTC) to 100 (WHO and ECOG). Interobserver disagreement of severity grading was partly due to different interpretation of scale parameters. Conclusions: Our results suggest that caution should be used in interpreting results across studies using different scales for neurotoxicity grading in chemotherapy-related peripheral neuropathy. When (multicentre) trials are to be undertaken with potential neurotoxic or neuroprotective agents, consensus should be sought regarding the toxicity rating scale used, and its interpretation by participating physicians.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1008344507482
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  • 3
    Electronic Resource
    Electronic Resource
    Pharmacokinetic schedule finding study of the combination of gemcitabine and cisplatin in patients with solid tumors (1999)
    Springer
    Annals of oncology 10 (1999), S. 441-448 
    Details
    ISSN: 1569-8041
    Keywords: cisplatin ; dFdCTP accumulation ; gemcitabine ; pharmacodynamics ; pharmacokinetics ; phase I study ; Pt-DNA adducts
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Purpose: To determine possible schedule dependent pharmacokinetic and pharmacodynamic interactions between gemcitabine (2′,2′-difluorodeoxycytidine, dFdC) and cisplatin (cis-diamminedichloroplatinum, CDDP) in patients with advanced stage solid tumors in a phase I trial. Patients and methods: A total of 33 patients with advanced stage solid tumors were treated with gemcitabine (30-min infusion, 800 mg/m2) and cisplatin (one-hour infusion, 50 mg/m2). Sixteen patients had a four-hour interval between gemcitabine (days 1, 8, 15) and cisplatin (days 1 and 8), followed by the reverse schedule and seventeen patients had a 24-hour interval between gemcitabine (days 1, 8, 15) and cisplatin (days 2 and 9), followed by the reverse schedule. Gemcitabine and cisplatin pharmacokinetics were measured in plasma and white blood cells (WBC), isolated from blood samples taken at several time points after the start of treatment. Results: A four-hour time interval between both agents did not reveal major differences in plasma pharmacokinetics of gemcitabine, dFdU (deaminated gemcitabine) and platinum (Pt), and of gemcitabine–triphosphate (dFdCTP) accumulation and Pt-DNA adduct formation in WBC between the two different sequences of gemcitabine and cisplatin. In the patients treated with the 24-hour interval, cisplatin before gemcitabine did not significantly change peak gemcitabine levels and the AUC of plasma dFdU, but tended to increase dFdCTP AUC in WBC 1.5-fold (P 〈 0.06). Gemcitabine before cisplatin decreased the plasma AUC of Pt 2.1-fold (P = 0.03). No significant differences in Pt-DNA adduct levels in WBC were found, although gemcitabine before cisplatin tended to increase the 24-hour retention of Pt-DNA adducts. Creatinine clearance on day 28 was related to the peak plasma levels of total Pt (linear regression coefficient (r) = 0.47, P = 0.02, n = 26). Furthermore, the increase in the Pt-GG to Pt-AG ratio 24 hours after cisplatin treatment was related to the overall response of patients (r = 0.89, P 〈 0.01, n = 8). Conclusions: Of all schedules the treatment of patients with cisplatin 24 hours before gemcitabine led to the highest dFdCTP accumulation in WBC and total Pt levels in plasma. These characteristics formed the basis for further investigation of this schedule in a phase II clinical study.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1008301522349
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  • 4
    Electronic Resource
    Electronic Resource
    Multiple cycles of high-dose doxorubicin and cyclophosphamide with G-CSF mobilized peripheral blood progenitor cell support in patients with metastatic breast cancer (1997)
    Springer
    Annals of oncology 8 (1997), S. 957-962 
    Details
    ISSN: 1569-8041
    Keywords: breast cancer ; high-dose chemotherapy
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background: In a previous study we applied doxorubicin and cyclophosphamide in a dose-intensive regimen with GM-CSF to patients with metastatic breast cancer (MBC). That treatment failed to prolong the remission duration compared to conventional-dose chemotherapy. In the present study we escalated the dosages of the same agents to: 1) determine the maximum tolerated dosages (MTD) when given for three cycles with G-CSF mobilised peripheral blood progenitor cell (PBPC) reinfusion and 2) evaluate the antitumour effect of this regimen. Patients and methods: For mobilisation of PBPC, G-CSF 15 µg/kg/day was given subcutaneously (s.c.), and in subsequent cohorts leucapheresis was started on days 3, 4 or 6. The intention was to treat MBC patients with three cycles of doxorubicin and cyclophosphamide at a starting dose of doxorubicin 90 mg/m2 and cyclophosphamide 1000 mg/m2. Dosages were then escalated in subsequent cohorts of at least three patients. In case of dose-limiting mucositis, only the dose of cyclophosphamide was escalated in the next cohort. Results: Twenty-one patients entered this protocol, of which 18 patients received high-dose chemotherapy. The mobilisation of PBPC using G-CSF only was sufficient for three cycles of high-dose chemotherapy in 10 of 21 (47%) patients. Mucositis precluded dose escalation of doxorubicin beyond 110 mg/m2. The MTD in this combination was 110 mg/m2 for doxorubicin, and 4 g/m2 for cyclophosphamide, with haemorrhagic cystitis being the dose-limiting toxicity. The overall response rate was 78% (95% confidence interval (95% CI): 57%–97%), with 22% (95% CI: 3%–41%) complete responses. Conclusion: The MTD of this three cycle high-dose regimen was doxorubicin 110 mg/m2 and cyclophosphamide 4 g/m2 with mucositis and cystitis being dose-limiting toxicities. Although the primary aim was not the evaluation of antitumour effect, this high-dose regimen does not appear to provide an improvement of treatment results in comparison with our previous study with the same drugs at moderately high-dosages without stem cell support.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1008259518263
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  • 5
    Electronic Resource
    Electronic Resource
    The ESMO programme of certification and training for medical oncology (1998)
    Springer
    Annals of oncology 9 (1998), S. 585-587 
    Details
    ISSN: 1569-8041
    Keywords: certification ; ESMO-MORA ; medical oncology ; training programme
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract ESMO has designed a programme of certification and training in medicaloncology. In this paper the background of these programmes is given, and theprogramme of graduate education is described in greater detail. The standard requirements are a total training period of six years,beginning with a common internship in internal medicine of at least two years,followed by a training programme in oncology for three to four years, whichmust include at least one year of full-time clinical training in the diagnosisand management of neoplastic diseases, accompanied by one year of experiencein an ambulatory care setting.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1008276911705
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  • 6
    Electronic Resource
    Electronic Resource
    Randomized study of a short course of weekly cisplatin with or without amifostine in advanced head and neck cancer (1999)
    Springer
    Annals of oncology 10 (1999), S. 693-700 
    Details
    ISSN: 1569-8041
    Keywords: amifostine ; cisplatin ; cytoprotection ; head and neck cancer
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background: Cisplatin is one of the most active cytotoxic agents available for the treatment of patients with head and neck cancer. In a previous phase II study with weekly administration of cisplatin, a response rate of 51% was achieved. However, only in a minority of the patients the planned high dose intensity of 80 mg/m2/week could be reached because of toxicity, mainly thrombocytopenia and ototoxicity. Amifostine is a cytoprotective drug that can diminish the toxicity of alkylating agents and platinum compounds. Therefore the effect of amifostine on toxicity and activity of weekly cisplatin was investigated in a randomized study. Patients and methods: Patients with locally advanced, recurrent or metastatic head and neck cancer were eligible. Patients were randomized to weekly cisplatin 70 mg/m2 for six cycles preceded by amifostine 740 mg/m2, or cisplatin only. Cisplatin was administered in hypertonic saline (3% NaCl) as a one-hour infusion; amifostine was administered as a 15-minute infusion directly before the administration of cisplatin. Results: Seventy-four patients were entered in the study. The median number of cisplatin administrations was 6 (range 2–6), equal in both arms. In both treatment arms the median dose intensity of cisplatin achieved was the planned 70 mg/m2/week. In the cisplatin only arm 6 out of 206 cycles were complicated by thrombocytopenia grade 3 or 4 versus 1 of 184 cycles in the amifostine arm (P = 0.035). Hypomagnesaemia grade 2 + 3 was significantly less observed in the amifostine arm (P = 0.04). Neurotoxicity analyzed by serial vibration perception thresholds (VPT) showed a diminished incidence of subclinical neurotoxicity in the amifostine arm (P = 0.03). No protective effect on renal and ototoxicity could be shown. Hypotension was the main side effect of amifostine but only of relevance in one patient. The antitumor activity of cisplatin was preserved as 63% of the evaluable patients in the amifostine arm responded compared to 50% of the evaluable patients in the cisplatin alone arm. Conclusion: Our study indicated that in combination with weekly administered cisplatin amifostine reduced the risk of thrombocytopenia, hypomagnesemia as well as subclinical neurotoxicity, but did not result in a higher dose intensity of cisplatin. Addition of amifostine did not compromise the antitumor effect of cisplatin.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1008353505916
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  • 7
    Electronic Resource
    Electronic Resource
    Intergroup Collaboration in Ovarian Cancer: A Giant Step Forward (1999)
    Springer
    Annals of oncology 10 (1999), S. 83-86 
    Details
    ISSN: 1569-8041
    Keywords: Integroup trials ; international collaboration ; ovarian cancer
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract The rather slow evolution of so-called "optimal chemotherapy" for ovarian cancer is the result of suboptimal randomised clinical trials, not having the statistical power to identify truly superior regimens, and of the lack of systematic comparisons of new agents with relevant control arms. There is little doubt that we need international collaboration to move the field forward in a timely and coherent manner. European and transatlantic collaboration represents the beginning of the process and point to the success that can await us if the drive to work together remains strong. A similar organisation as for breast cancer (Breast International Group, BIG) needs to be established for ovarian cancer.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1008371821148
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  • 8
    Electronic Resource
    Electronic Resource
    Cytomegalovirus colitis after administration of docetaxel–5-fluorouracil–cisplatin chemotherapy for locally advanced hypopharyngeal cancer (1999)
    Springer
    Annals of oncology 10 (1999), S. 1369-1372 
    Details
    ISSN: 1569-8041
    Keywords: cancer ; chemotherapy ; colitis ; cytomegalovirus ; docetaxel ; hypopharynx
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract We present the case of a patient with a locally advanced hypopharyngeal carcinoma who developed a severe cytomegalovirus (CMV) colitis after his first chemotherapy course with 5-fluorouracil (5-FU), docetaxel and cisplatin. The most probable cause of his CMV colitis is the impaired immunity during a phase of neutropenia after the chemotherapy. Although there was amelioration of the colitis and clinical status after treatment with ganciclovir, the patient later deteriorated and died due to recurrent bacterial infections. This is the third reported case of CMV colitis treated with ganciclovir in a patient with a solid tumour. It is the first report of CMV colitis after docetaxel containing chemotherapy. Although CMV colitis is most frequently observed in immunosuppressed patients such as those with acquired immune deficiency syndrome (AIDS), transplants and corticosteroid treatment, it has also been reported in less immunosuppressed (elderly, malnourished, ...) and even non-immunosuppressed patients. CMV infection should therefore be included in the differential diagnosis of GI disease in all patients, and when suspected, the clinician should pursue appropriate diagnostic and therapeutic interventions.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1008357619646
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  • 9
    Electronic Resource
    Electronic Resource
    Gemcitabine–cisplatin: A schedule finding study (1999)
    Springer
    Annals of oncology 10 (1999), S. 1503-1510 
    Details
    ISSN: 1569-8041
    Keywords: cisplatin ; esophageal cancer ; gemcitabine ; schedule dependency
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Purpose: To evaluate the tolerability of four alternating cisplatin–gemcitabine schedules. A secondary aim was to evaluate the clinical efficacy of this combination. Patients and methods: Forty-one patients with advanced solid tumors received alternating sequences with a 4- and 24-hour interval of cisplatin and gemcitabine. Gemcitabine 800 mg/m2 was administered as a 30-min infusion on day 1, 8 and 15, and cisplatin 50 mg/m2 over 1 hour on day 1 and 8; in case of the 24-hour time interval the second drug was administered one day later. Four cisplatin–gemcitabine schedules were studied: gemcitabine four hour before cisplatin (10 patients), or vice versa (14 patients) and gemcitabine twenty-four hours before cisplatin (9 patients) or vice versa (8 patients). The sequence of drug administration was reversed in the second cycle of therapy in each individual patient, enabling the evaluation of sequence-dependent side effects. Twenty-six patients had received prior chemotherapy, of which twenty-one platinum-based. Results: The main toxicity was myelosuppression. Overall, grade 3 and 4 thrombocytopenia was observed in 27 out of 41 patients (66%) and was not schedule dependent. No serious bleeding occurred. Leukopenia was significantly different between the 4 alternating schedules (P = 0.01); gemcitabine 24 hours before cisplatin was significantly less toxic compared to both cisplatin 4 hours and 24 hours before gemcitabine (P = 0.01 and P = 0.003, respectively). Furthermore, paired analysis of the 4-hour and 24-hour data sets showed that leukopenia was significantly more serious when cisplatin preceded gemcitabine (P = 0.005). Although most patients received prior treatment, both prior chemotherapy and radiotherapy were not related to toxicity. Overall, grade 3 and 4 leukopenia occurred in 19 out of 41 patients (46%). Anemia (Hb ≤6.0 mmol/l) was not sequence dependent and was observed in 63% of patients. Myelotoxicity was cumulative between cycles and caused frequent omission of gemcitabine on day 15. Overall, in 51% of administered cycles there was no omission of gemcitabine. A mean of 3.5 therapy cycles was administered. Non-hematological toxicity was moderate, consisting mainly of grade 1 and 2 nausea/vomiting and fatigue, and was not schedule dependent. Recently, we described that the schedule in which cisplatin was administered 24 hours before gemcitabine produced the best pharmacological profile. Based on this and because toxicity was manageable, the schedule cisplatin 24 hours prior to gemcitabine was chosen for phase II evaluation. Nine out of thirty-six evaluable patients had an objective response. These responses were observed in head and neck squamous-cell carcinoma (HNSCC), non-small-cell lung cancer (NSCLC), melanoma, adenocarcinoma of unknown origin, ovarian and esophageal carcinoma. Conclusions: Myelosuppression was the most important toxicity. Leukopenia was schedule dependent: gemcitabine before cisplatin was less toxic than the reversed sequence, in this respect. Some encouraging responses were seen in patients with esophageal cancer. Currently, a phase II study with cisplatin 24 hours before gemcitabine is ongoing in patients with advanced upper gastro-intestinal tumors.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1008339425708
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  • 10
    Electronic Resource
    Electronic Resource
    The Role of Anthracyclines in Epithelial Ovarian Cancer (1999)
    Springer
    Annals of oncology 10 (1999), S. 43-50 
    Details
    ISSN: 1569-8041
    Keywords: doxorubicin ; epirubicin ; liposomal doxorubicin ; ovarian cancer
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract This paper provides a survey on anthracycline treatment in ovarian cancer, focusing on toxicity and analysis of treatment results. Meta-analyses and studies in which anthracyclines have been combined with "standard" taxoid regimens are reviewed. The data suggest that the addition of an anthracycline to front-line non-taxoid based therapy is beneficial. The addition of an anthracycline to a combination of a taxoid and platinum derivative is rationale and feasible and randomised trials are on their way to completion. It is important that the final conclusions of these studies are based on long-term survival data, not just on the assessment of median differences in survival.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1008307401584
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