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See detailEvaluation of Everolimus (EVE) in HER2+ advanced breast cancer (BC) with activated PI3K/mTOR pathway : exploratory biomarker observations from the BOLERO-3 trial
JERUSALEM, Guy ULg; ANDRE, Fabrice; CHEN, David et al

in European Journal of Cancer (2013, September), 49(Supplement 3), 8

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See detailDo results of the EORTC dummy run predict quality of radiotherapy delivered within multicentre clinical trials?
Fairchild, A.; Collette, L.; Hurkmans, C. W. et al

in European Journal of Cancer (2012), 48(17), 3232-3239

Objective: The European Organisation for the Research and Treatment of Cancer (EORTC) Radiation Oncology Group (ROG) has performed radiotherapy quality assurance (QA) in clinical trials, including dummy ... [more ▼]

Objective: The European Organisation for the Research and Treatment of Cancer (EORTC) Radiation Oncology Group (ROG) has performed radiotherapy quality assurance (QA) in clinical trials, including dummy runs (DR) and individual case reviews (ICR), since 1991. We investigated the influence of DR results on subsequent QA and patient outcomes. Methods: EORTC ROG studies were reviewed for DR inclusion, QA and mature clinical outcomes. A DR was classified as a failure if corrections necessitated re-submission. ICR were graded as acceptable, minor or major deviation overall. Fisher's exact test characterised potential correlations and the Mantel-Haenszel statistic quantified pooled odds ratios (OR). Results: DR and ICR data were available from 12 and 3 protocols, respectively. The proportion of institutions successful at first DR attempt varied per trial from 5.6% to 68.8%. Participants were 3.2 times more likely to pass at first attempt after previous DR participation (p = 0.0002). Pooled OR for an acceptable ICR was 1.69 (p = 0.06) for institutions successful at DR first attempt. The effect of DR participation was not significantly correlated with patient outcome in the trial available for analysis. Conclusions: Implementing QA measures in ROG clinical trials should ensure optimal radiotherapy delivery. Centres which previously participated in a DR were significantly more likely to be successful at subsequent QA procedures. © 2012 Elsevier Ltd. All rights reserved. [less ▲]

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See detailPreclinical evidence for a beneficial impact of valproate on the response of small cell lung cancer to first-line chemotherapy
Hubaux, Roland; Vandermeers, Fabian ULg; Crisanti, Cecilia et al

in European Journal of Cancer (2010), 46

Prognosis of small cell lung carcinoma (SCLC) is particularly poor, less than 5% of patients with extensive stage being alive after two years.We hypothesized that SCLC chemotherapy could be improved by ... [more ▼]

Prognosis of small cell lung carcinoma (SCLC) is particularly poor, less than 5% of patients with extensive stage being alive after two years.We hypothesized that SCLC chemotherapy could be improved by using histone deacetylase (HDAC) inhibitors based on their ability to interfere with lysine acetylation and to alter gene expression. The goal of this study was to evaluate the anticancer efficacy of a HDAC inhibitor (valproate: VPA) on SCLC cells in combination with the standard chemotherapeutic first-line regimen (cisplatin + etoposide). We show that VPA induces apoptosis of small cell lung cancer cell lines and improves efficacy of cisplatin combined with etoposide. Both mitochondrial and death receptor pathways are involved in VPA-induced apoptosis. As expected for an HDAC inhibitor, VPA hyperacetylates histone H3. The mechanism of VPA pro-apoptotic activity involves induction of p21, inhibition of Bcl-xL, cleavage of Bid and phosphorylation of Erk and H2AX. In the presence of VPA, Bax is translocated from the cytoplasm to the mitochondria and cleaved in an 18 kDa isoform. Cytochrome c is released from the mitochondria into the cytosol. Transcriptomic analyses by microarray show that VPA modulates transcription of genes (Na+/ K+ ATPase, Bcl-xL) involved in chemoresistance to cisplatin and etoposide. Finally, the efficacy of VPA combined with cisplatin and etoposide is supported by preclinical models of SCLC cells engrafted into SCID mice. Together, these data demonstrate that VPA augments anticancer activity of cisplatin and etoposide, two components of the standard first-line chemotherapy of small cell lung cancer. [less ▲]

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See detailAcute toxicity of curative radiotherapy for intermediate- and high-risk localised prostate cancer in the EORTC trial 22991
Matzinger, O.; Duclos, F.; Bergh, A. V D et al

in European Journal of Cancer (2009), 45(16), 2825-2834

Introduction: This trial randomly assessed short-term adjuvant hormonal therapy added to radiotherapy (RT) for intermediate- and high-risk (UICC 1997 cT2a or cT1b-c with high PSA or Gleason score ... [more ▼]

Introduction: This trial randomly assessed short-term adjuvant hormonal therapy added to radiotherapy (RT) for intermediate- and high-risk (UICC 1997 cT2a or cT1b-c with high PSA or Gleason score) localised prostate cancer. We report acute toxicity (CTCAE v2) assessed weekly during RT in relation to radiation parameters. Patients and methods: Centres selected the RT dose (70, 74 or 78 Gy) and RT technique. Statistical significance is at 0.05. Results: Of 791 patients, 652 received 3D-CRT (70 Gy: 195, 74 Gy: 376, 78 Gy: 81) and 139 received IMRT (74 Gy: 28, 78 Gy: 111). During RT, grade 3 gastrointestinal (GI) and genitourinary (GU) toxicities were reported by7 (0.8%) and 50 (6.3%) patients, respectively. No grade 4 was reported. The risk of grade ≥2 GI toxicity increased significantly with increasing D50%-rectum (p = 0.004) and that of grade ≥2 GU toxicity correlated only to Dmax-bladder (p = 0.051). 3D-RT technique, increasing total dose and V95% >400 cc increased D50% and Dmax. One month after RT, only 14 patients (1.8%) reported grade 3 toxicity. AST did not seem to influence the risk of GU or GI acute toxicity. Conclusion: RT up to 78 Gy was well tolerated. Dmax-bladder and D50%-rectum influenced the risk of grade ≥2 GU toxicity and GI toxicity, respectively. Both were lower with IMRT but remained high for an irradiated RT volume > 400 cc for 3D-RT and for a dose of 78 Gy. Hormonal treatment did not influence acute toxicity. © 2009 Elsevier Ltd. All rights reserved. [less ▲]

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See detailAssociation of Simian Virus 40 (SV40) with human breast carcinomas in Tunisian women
Hachana, Mohamed Ridha ULg; Trimeche, Mounir; Ziadi, Sonia et al

in European Journal of Cancer (2008), 6(9), 195

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See detailProfile of methylaion of tumour related genes in breast cancer in Tunisian women
Hachana, Mohamed Ridha ULg; Trimeche, Mounir; Ziadi, Sonia et al

in European Journal of Cancer (2008), 6(9), 195

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See detailPhosphorylated HER-2 tyrosine kinase and Her-2/neu gene amplification as predictive factors of response to trastuzumab in patients with HER-2 overexpressing metastatic breast cancer (MBC).
Giuliani, Rosa; Durbecq, Virginie; Di Leo, Angelo et al

in European Journal of Cancer (2007), 43(4), 725-35

AIM: Trastuzumab (T), a humanised monoclonal antibody against HER-2, is active in HER-2-positive MBC patients. However, nearly 60% of the patients do not benefit from T, stressing the need for additional ... [more ▼]

AIM: Trastuzumab (T), a humanised monoclonal antibody against HER-2, is active in HER-2-positive MBC patients. However, nearly 60% of the patients do not benefit from T, stressing the need for additional predictive markers. The following markers could be implicated in response to T: (1) the magnitude of Her-2 gene amplification; (2) the co-expression of the other HER family receptors, possibly responsible for HER-2 trans-activation; (3) the activated status of HER-2; (4) the activated status of downstream effectors as mitogen-activated protein kinases (MAPKs), p38 and p27. METHODS: Medical files of patients with MBC treated with T either as a single agent or in combination with chemotherapy (CT) were reviewed. HER family members (EGFR, HER-2, HER-3, HER-4), the phosphorylated forms of EGFR (p-EGFR), HER-2 (p-HER-2) and of the downstream effectors were evaluated in the archival tumours. The correlation between clinical outcome and the expression of these markers was investigated. RESULTS: (1) Increasing values of Her-2 amplification were associated with a higher probability of achieving an objective response; (2) no statistical significant correlation between the expression of the HER family receptors was found; (3) p-HER-2 was predictive of response in patients treated with T+CT; (4) a statistically significant correlation between p-ERK 1/2, p-p38 and p-HER-2 emerged, pointing to the activated vertical pathway p-HER-2-->p-MAPKs. CONCLUSIONS: p-HER-2 and the magnitude of Her-2 amplification were predictive of response to T and their role deserves to be analysed in larger and more homogenous T-treated populations such as those from large phase III trials. [less ▲]

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See detailDoes a patient's self-reported health-related quality of life predict survival beyond key biomedical data in advanced colorectal cancer? (vol 42, pg 42, 2006)
Efficace, Fabio; Bottomley, Andrew; Coens, Corneel et al

in European Journal of Cancer (2007), 43(3), 633-633

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See detailDoes a patient's self-reported health-related quality of life predict survival beyond key biomedical data in advanced colorectal cancer?
Efficace, F.; Bottomley, A.; Coens, C. et al

in European Journal of Cancer (2006), 42(1), 42-9

The purpose of this study was to determine whether baseline patients' self reported health-related quality of life (HRQOL) parameters could predict survival beyond key biomedical prognostic factors in ... [more ▼]

The purpose of this study was to determine whether baseline patients' self reported health-related quality of life (HRQOL) parameters could predict survival beyond key biomedical prognostic factors in patients with metastatic colorectal cancer. The analysis was conducted on 299 patients. HRQOL baseline scores were assessed using the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire-Core30 (EORTC QLQ-C30). The Cox proportional hazards regression model was used for both univariate and multivariate analyses of survival. In addition, a bootstrap resampling technique was used to assess the stability of the outcomes. The final multivariate Cox regression model retained four variables as independent prognostic factors for survival: white blood cell (WBC) count with a hazard ratio (HR) of 1.961 (95% CI, 1.439-2.672; P<0.001), alkaline phosphatase with HR=1.509 (95% CI, 1.126-2.022; P=0.005), number of sites involved with HR=1.108 (95% CI, 1.024-1.198; P=0.01) and the patient's score on the social functioning scale with HR=0.991 (95% CI, 0.987-0.996; P<0.001) which translates into a 9% decrease in the patient's hazard of death for any 10 point increase. The independent prognostic importance of social functioning and the stability of the final Cox regression model were also confirmed by the additional bootstrap model averaging analysis, based on 1000 bootstrap-generated samples. The results suggest that social functioning, acts as a prognostic measure of survival beyond a number of previously known biomedical parameters. [less ▲]

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See detailBaseline health-related quality-of-life data as prognostic factors in a phase III multicentre study of women with metastatic breast cancer
Efficace, F.; Biganzoli, L.; Piccart, M. et al

in European Journal of Cancer (2004), 40(7), 1021-1030

The potential value of baseline health-related quality-of-life (HRQOL) and clinical factors in predicting prognosis was examined using data from an international randomised phase III trial which compared ... [more ▼]

The potential value of baseline health-related quality-of-life (HRQOL) and clinical factors in predicting prognosis was examined using data from an international randomised phase III trial which compared doxorubicin and paclitaxel with doxorubicin and cylophosphamide as first line chemotherapy in 275 women with metastatic breast cancer. The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and the related breast module (QLQ-BR23) were used to assess baseline HRQOL data. The Cox proportional-hazards regression model was used for both univariate and multivariate analyses of survival. In the univariate analyses, performance status (P < 0.001) and number of sites involved (P = 0.001) were the most important clinical prognostic factors. The HRQOL variables at baseline most strongly associated with longer survival were better appetite, physical and role functioning, as well as less fatigue (P < 0.001). The final multivariate model retained performance status (P < 0.001) and appetite loss (P = 0.005) as the variables best predicting survival. Substantial loss of appetite was the only independent HRQOL factor predicting poor survival and was strongly correlated (\r\ > 0.5) with fatigue, role and physical functioning. In addition to known clinical factors, appetite loss appears to be a significant prognostic factor for survival in women with metastatic breast cancer. However, the mechanism underlying this association remains to be precisely defined in future studies. (C) 2004 Elsevier Ltd. All rights reserved. [less ▲]

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See detailPositive interactive radiosensitization observed in vitro with the combination of two nucleoside analogs (E)-2'-deoxy-2'-(fluoromethylene) cytidine (FMdC) and iododeoxyuridine (IdUrd).
Coucke, Philippe ULg; Cottin, E; Azria, D et al

in European Journal of Cancer (2004)

(E)-20-Deoxy-20-(fluoromethylene) cytidine (FMdC), an inhibitor of ribonucleotide diphosphate reductase (RR), is a potent radiation-sensitiser acting through alterations in the deoxyribonucleoside ... [more ▼]

(E)-20-Deoxy-20-(fluoromethylene) cytidine (FMdC), an inhibitor of ribonucleotide diphosphate reductase (RR), is a potent radiation-sensitiser acting through alterations in the deoxyribonucleoside triphosphate (dNTP) pool in the de novo pathway to DNA synthesis. The activity of thymidine kinase (TK), a key enzyme in the ‘salvage pathway’, is known to increase in response to a lowering of dATP induced by FMdC. Nucleoside analogues such as iododeoxyuridine (IdUrd) are incorporated into DNA after phosphorylation by TK. Radiation sensitisation by IdUrd depends on IdUrd incorporation. Therefore, we have investigated the radiosensitising effect of the combination of FMdC and IdUrd on WiDr (a human colon cancer cell-line) and compared it to the effect of either drug alone. We analysed the effects of FMdC and IdUrd on the dNTP pools by high-performance liquid chromatography, and measured whether the incorporation of IdUrd was increased by FMdC using a [125I]-IdUrd incorporation assay. The combination in vitro yielded radiation-sensitiser enhancement ratios of >2, significantly higher than those observed with FMdC or IdUrd alone. Isobologram analysis of the combination indicated a supra-additive effect. This significant increase in radiation sensitivity with the combination of FMdC and IdUrd could not be explained by changes in the dNTP pattern since the addition of IdUrd to FMdC did not further reduce the dATP. However, the increase in the radiation sensitivity of WiDr cells might be due to increased incorporation of IdUrd after FMdC treatment. Indeed, a specific and significant incorporation of IdUrd into DNA could be observed with the [125I]-IdUrd incorporation assay in the presence of 1 lM unlabelled IdUrd when combined with FMdC treatment. 2004 Elsevier Ltd. All rights reserved. [less ▲]

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See detailShortened irradiation scheme, continuous infusion of 5-fluorouracil and fractionation of mitomycin C in locally advanced anal carcinomas. Results of a phase II study of the European Organization for Research and Treatment of Cancer. Radiotherapy and Gastrointestinal Cooperative Groups
Bosset, J. F.; Roelofsen, F.; Morgan, D. A. L. et al

in European Journal of Cancer (2003), 39

Abstract The European Organization for Research and Treatment of Cancer (EORTC) 22861 randomised trial established that combined radiochemotherapy is the standard treatment for locally advanced anal ... [more ▼]

Abstract The European Organization for Research and Treatment of Cancer (EORTC) 22861 randomised trial established that combined radiochemotherapy is the standard treatment for locally advanced anal cancer. This EORTC phase II study (#22953) tests the feasibility of reducing the gap between sequences to 2 weeks, to deliver Mitomycin C (MMC) in each radiotherapy sequence and 5-FU continuously during the treatment. The first sequence consisted of 36 Gy over 4 weeks. 5-FU 200 mg/m2/days 1–26, MMC 10 mg/m2/day 1 gap 16 days. Then a second sequence of 23.4 Gy over 17 days, 5-FU 200 mg/m2/days 1–17 and, MMC 10 mg/m2/day 1 was given. 43 patients with a World Health Organization (WHO) status of 0 (n=27) or 1 (n=16) and with T2-T4, N0-3 tumours were included. Compliance with the planned treatment, doses and duration was 93%. The complete response rate was 90.7%. Grade 3 toxicities of 28, 12 and 2% were observed for skin, diarrhoea and haematological toxicities, respectively. The 3-year estimated rates for trials 22861 and 22953 are: 68 and 88% for local control; 72 and 81% for colostomy-free interval, 62 and 84% for severe late toxicity-free interval, and 70 and 81% for survival, respectively. The 22953 scheme is feasible and the results are promising. This is now considered as the new standard scheme by the EORTC. [less ▲]

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See detailPET scan imaging in oncology.
Jerusalem, Guy ULg; Hustinx, Roland ULg; Beguin, Yves ULg et al

in European Journal of Cancer (2003), 39(11), 1525-34

With the emergence of positron emission tomography (PET) from research laboratories into routine clinical use, it is important to redefine the most appropriate use of each imaging technique. The aim of ... [more ▼]

With the emergence of positron emission tomography (PET) from research laboratories into routine clinical use, it is important to redefine the most appropriate use of each imaging technique. The aim of this review article is to show the potential of PET in oncology. We discuss the most promising indications and the perspectives for the future. We will also point out the shortcomings and the important questions to be answered before fully considering PET as a necessary tool in the day-to-day practice of oncology. Although many studies have documented the high accuracy of 18F-FDG PET for the detection and staging of malignant tumours and for the monitoring of therapy results in these patients, it is very important to assess the impact of the technique on patient outcome and to show cost-effectiveness from the societal viewpoint. [less ▲]

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See detailRadiation therapy alone or combined surgery and radiation therapy in squamous-cell carcinoma of the penis?
Zouhair, A; COUCKE, Philippe ULg; Jeanneret, W et al

in European Journal of Cancer (2001), 37

Abstract To assess the prognostic factors and the outcome in patients with squamous-cell carcinoma of the penis, a retrospective review of 41 consecutive patients with non-metastatic invasive carcinoma of ... [more ▼]

Abstract To assess the prognostic factors and the outcome in patients with squamous-cell carcinoma of the penis, a retrospective review of 41 consecutive patients with non-metastatic invasive carcinoma of the penis, treated between 1962 and 1994, was performed. The median age was 59 years (range: 35±76 years). According to the International Union Against Cancer (UICC) 1997 classi®cation, there were 12 (29%) T1, 24 (59%) T2, 4 (10%) T3 and 1 TX (2%) tumours. The N-classi®cation was distributed as follows: 29 (71%) patients with N0, 8 (20%) with N1, 3 (7%) with N2 and 1 (2%) with N3. Forty-four per cent (n=18) of the patients underwent surgery: partial penectomy with (n=4) or without (n=12) lymph node dissection, or total penectomy with (n=1) or without (n=1) lymph node dissection. 23 patients were treated with radiation therapy alone, and all but 4 of the patients who were operated upon received postoperative radiation therapy (n=14). The median follow-up period was 70 months (range 20±331 months). In a median period of 12 months (range 5±139 months), 63% (n=26) of the patients relapsed (local in 18, locoregional in 2, regional in 3 and distant in 3). Local failure (stump in the operated patients, and the tumour bed in those treated with primary radiation therapy) was observed in 4 out of 16 (25%) patients treated with partial penectomy postoperative radiotherapy versus 14 out of 23 (61%) treated with primary radiotherapy (P=0.06). 15 (83%) out of 18 local failures were successfully salvaged with surgery. In all patients, 5- and 10-year survival rates were 57% (95% con®dence interval (CI), 41±73%) and 38% (95% CI, 21± 55%), respectively. The 5-year local and locoregional rates were 57% (95% CI, 41±73%) and 48% (95% CI, 32±64%), respectively. In patients treated with primary radiotherapy, 5- and 10-year probabilities of surviving with penis preservation were 36% (95% CI, 22±50%) and 18% (95% CI, 2±34%), respectively. In multivariate analyses, survival was signi®cantly in¯uenced by the N-classi®- cation, and surgery was the only independent factor predicting the locoregional control. We conclude that, in patients with squa- mous-cell carcinoma of the penis, local control is better in patients treated with surgery. However, there seems to be no di erence in terms of survival between patients treated by surgery and those treated by primary radiotherapy salvage surgery, with 39% having organ preservation. [less ▲]

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See detailProgesterone Receptor Activation. An Alternative to SERMs in Breast Cancer
Desreux, Joëlle ULg; Kebers, F.; Noël, Agnès ULg et al

in European Journal of Cancer (2000), 36(Suppl 4), 90-1

Data regarding the effects of progesterone and a progestagen on human normal breast epithelial cell proliferation and apoptosis are presented here. In postmenopausal women, adding progesterone to ... [more ▼]

Data regarding the effects of progesterone and a progestagen on human normal breast epithelial cell proliferation and apoptosis are presented here. In postmenopausal women, adding progesterone to percutaneously administrated oestradiol significantly reduces the proliferation induced by oestradiol. In vitro and in premenopausal women, stopping the administration of nomegestrol acetate triggers a peak of apoptosis. Fibro-adenoma and cancerous cells do not show this regulation of apoptosis. Progesterone seems to be important in normal breast homeostasis. [less ▲]

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See detailRadiation therapy alone or combined surgery and radiation therapy in squamous-cell carcinoma of the penis?
Zouhair, A; COUCKE, Philippe ULg; Jeanneret, W et al

in European Journal of Cancer (2000), 37(2), 198203

To assess the prognostic factors and the outcome in patients with squamous-cell carcinoma of the penis, a retrospective review of 41 consecutive patients with non-metastatic invasive carcinoma of the ... [more ▼]

To assess the prognostic factors and the outcome in patients with squamous-cell carcinoma of the penis, a retrospective review of 41 consecutive patients with non-metastatic invasive carcinoma of the penis, treated between 1962 and 1994, was performed. The median age was 59 years (range: 35–76 years). According to the International Union Against Cancer (UICC) 1997 classification, there were 12 (29%) T1, 24 (59%) T2, 4 (10%) T3 and 1 TX (2%) tumours. The N-classification was distributed as follows: 29 (71%) patients with N0, 8 (20%) with N1, 3 (7%) with N2 and 1 (2%) with N3. Forty-four per cent (n=18) of the patients underwent surgery: partial penectomy with (n=4) or without (n=12) lymph node dissection, or total penectomy with (n=1) or without (n=1) lymph node dissection. 23 patients were treated with radiation therapy alone, and all but 4 of the patients who were operated upon received postoperative radiation therapy (n=14). The median follow-up period was 70 months (range 20–331 months). In a median period of 12 months (range 5–139 months), 63% (n=26) of the patients relapsed (local in 18, locoregional in 2, regional in 3 and distant in 3). Local failure (stump in the operated patients, and the tumour bed in those treated with primary radiation therapy) was observed in 4 out of 16 (25%) patients treated with partial penectomy ±postoperative radiotherapy versus 14 out of 23 (61%) treated with primary radiotherapy (P=0.06). 15 (83%) out of 18 local failures were successfully salvaged with surgery. In all patients, 5- and 10-year survival rates were 57% (95% confidence interval (CI), 41–73%) and 38% (95% CI, 21–55%), respectively. The 5-year local and locoregional rates were 57% (95% CI, 41–73%) and 48% (95% CI, 32–64%), respectively. In patients treated with primary radiotherapy, 5- and 10-year probabilities of surviving with penis preservation were 36% (95% CI, 22–50%) and 18% (95% CI, 2–34%), respectively. In multivariate analyses, survival was significantly influenced by the N-classification, and surgery was the only independent factor predicting the locoregional control. We conclude that, in patients with squamous-cell carcinoma of the penis, local control is better in patients treated with surgery. However, there seems to be no difference in terms of survival between patients treated by surgery and those treated by primary radiotherapy ±salvage surgery, with 39% having organ preservation. [less ▲]

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See detailClinical Activity and Benefit of Irinotecan (CPT-11) in Patients with Colorectal Cancer Truly Resistant to 5-Fluorouracil (5-FU)
Van Cutsem, Eric; Cunningham, D.; Ten Bokkel Huinink, W. W. et al

in European Journal of Cancer (1999), 35

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See detailPredicting response in head and neck cancer: The search for the holy grall
COUCKE, Philippe ULg

in European Journal of Cancer (1997), 33(supp 8), 289-290

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See detailTnp-470 (Agm-1470): Mechanisms of Action and Early Clinical Development
Castronovo, Vincenzo ULg; Belotti, D.

in European Journal of Cancer (1996), 32A(14), 2520-7

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