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M Vaes,
D Bron,
DJ Vugts, M Paesmans,
N Meuleman,
G Ghanem,
T Guiot,
B Vanderlinden,
K Thielemans,
GAMS van Dongen,
P. Flamen,
K. Muylle
Journal of Cancer Science and Therapy 11/2012; 4(12):394-400.
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T Berghmans,
J J Lafitte,
V Giner,
M C Berchier,
A Scherpereel,
D Lewin, M Paesmans,
A P Meert,
T Bosschaerts,
N Leclercq,
J P Sculier
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ABSTRACT: Induction cisplatin-based CT improves survival in resectable non-small cell lung cancer (NSCLC). We aimed to determine the respective activity of third-generation (gemcitabine-vinorelbine-cisplatin [GVP]) in comparison with second-generation drugs CT (mitomycine-ifosfamide-cisplatin [MIP]) and their cost-effectiveness as neoadjuvant CT before surgery in NSCLC. Patients with histologically proven initially untreated resectable stages I-III NSCLC were randomised between three courses of MIP or GVP followed by surgery. A two-stage Simon design was used for each arm with resectability rate as primary endpoint. A cost minimisation analysis, considering the direct medical costs, was performed in the Belgian and French social security systems. From 2001 to 2007, 140 patients (pts) were randomised (MIP 69, GVP 71). Main characteristics were: stage I/II/III in 52, 37 and 51 pts, squamous histology in 82 pts, male 114 pts, median PS 90. Objective response rates to induction CT were 60% (MIP) and 65% (GVP) (p=0.55). Complete resection rates were 77% (MIP) and 80% (GVP) (p=0.62). Median survival times were 47.2 months (MIP) and 36.6 months (GVP) (p=0.41). Cost-analyses showed significant incremental costs with GVP. In conclusion, while both neoadjuvant chemotherapy regimens shared similar efficacy in patients with resectable NSCLC, costs were significantly higher for third-generation regimens.
Lung cancer (Amsterdam, Netherlands) 06/2012; 77(3):605-10. · 3.14 Impact Factor
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[show abstract]
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ABSTRACT: The pattern recognition molecules H-ficolin, L-ficolin and M-ficolin bind to micro-organisms. They activate the lectin pathway of complement through mannan-binding lectin (MBL)-associated serine proteases (MASPs). Association between low MBL levels and infections in patients undergoing chemotherapy for haematological diseases has been observed previously. We now examine for MASP-2, MASP-3 and ficolin levels. We assessed the concentration of lectin pathway molecules as risk factors for infection in patients with haematological malignancy undergoing chemotherapy. Samples taken before the initiation of chemotherapy covering 117 chemotherapy cycles in 105 patients were available. MASPs and ficolins were measured by time-resolved immunoflourometric assays and the levels related to parameters of infections. End-points included febrile neutropenia, documented infections, bacteraemia or severe infections. Lower M-ficolin concentrations were found in patients who developed a severe infection: median 0·27 µg/ml compared to 0·47 µg/ml in patients who did not develop a severe infection (P = 0·01). Conversely, MASP-2 was higher in these patients: median 0·53 µg/ml compared to 0·37 µg/ml, respectively (P = 0·008). When considering M-ficolin levels below 0·36 µg/ml as deficient, the time to development of severe infection was shorter in the M-ficolin deficient group: the hazard ratio was 2·60 (95% confidence interval: 1·23-5·49). No associations were revealed between infections and H-ficolin, L-ficolin or MASP-3. Patients with low M-ficolin are more likely to develop severe infections, whereas MASP-2 showed the opposite.
Clinical & Experimental Immunology 02/2012; 167(2):303-8. · 3.36 Impact Factor
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A Hendlisz,
V Golfinopoulos,
C Garcia,
A Covas,
P Emonts,
L Ameye, M Paesmans,
A Deleporte,
G Machiels,
E Toussaint,
B Vanderlinden,
A Awada,
M Piccart,
P Flamen
[show abstract]
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ABSTRACT: The study purpose was to assess the predictive value of 2-[fluorine-18]fluoro-2-deoxy-D-glucose (FDG)-positron emission tomography (PET)/computerized tomography (CT) metabolic response after a single course of chemotherapy in patients with metastatic colorectal cancer (mCRC).
FDG-PET/CT scans were carried out at baseline and on day 14 in 41 patients with unresectable mCRC treated with a biweekly regimen of chemotherapy. Metabolic nonresponse was defined by <15% decrease in FDG uptake in the dominant proportion of the patient's lesions or if a lesion was found metabolically progressive. The PET-based response was correlated with radiological response (primary end point) and patient's outcome (secondary end points).
RECIST response rate in metabolically responding patients was 43% (10 of 23) compared with 0% (0 of 17) in nonresponding patients (P=0.002). The metabolic assessment's predictive performance for RECIST response was sensitivity 100% [95% confidence interval (CI) 69% to 100%], specificity 57% (95% CI 37% to 75%), positive predictive value 43% (95% CI 23% to 66%), and negative predictive value 100% (95% CI 80% to 100%). Comparing metabolically responding versus nonresponding patients, the hazard ratio (HR) was 0.28 (95% CI 0.10-0.76) for overall survival and 0.57 (95% CI 0.27-1.21) for progression-free survival.
The metabolic response measured by FDG-PET/CT after a single course of chemotherapy in mCRC is able to identify patients who will not benefit from the treatment.
Annals of Oncology 11/2011; 23(7):1687-93. · 6.43 Impact Factor
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K S Saini,
C Taylor,
A-J Ramirez,
C Palmieri,
U Gunnarsson,
H J Schmoll,
S M Dolci,
C Ghenne,
O Metzger-Filho,
M Skrzypski, M Paesmans,
L Ameye,
M J Piccart-Gebhart,
E de Azambuja
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ABSTRACT: The optimal management of patients with breast cancer (BC) requires the expertise of specialists from different disciplines. This has led to the evolution of multidisciplinary teams (MDTs), allowing all key professionals to jointly discuss individual patients and to contribute independently to clinical decisions. Data regarding BC MDTs in different regions and countries are scarce.
The investigators of a large global phase III adjuvant BC trial being conducted by the Breast International Group were invited to respond to a questionnaire about the extent, structure, and function of BC MDTs.
One hundred and fifty-two responses from 39 countries were received, and remarkable differences were noted in different geographic regions. Sixty-five percent of the respondents from eastern Europe, 63% from western Europe, 35% from Asia, and 25% from South America declared that MDT was a mandatory part of BC care in their country. Ninety percent of the respondents from Europe stated their MDTs met weekly, compared with only half of the respondents from Asia.
This survey is perhaps the first large-scale effort to collect information regarding BC MDTs from different parts of the world and provides objective information of frequency, composition, function, and working mechanism of BC MDTs.
Annals of Oncology 08/2011; 23(4):853-9. · 6.43 Impact Factor
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T Berghmans,
F Pasleau, M Paesmans,
Y Bonduelle,
J Cadranel,
I Cs Toth,
C Garcia,
V Giner,
S Holbrechts,
J J Lafitte, [......],
A P Meert,
M Richez,
M Roelandts,
A Scherpereel,
Ch Tulippe,
P Van Houtte,
P Van Schil,
C Wachters,
V Westeel,
J P Sculier
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ABSTRACT: The present systematic review was performed under the auspices of the European Lung Cancer Working Party (ELCWP) in order to determine the role of early intermediate criteria (surrogate markers), instead of survival, in determining treatment efficacy in patients with lung cancer. Initially, the level of evidence for the use of overall survival to evaluate treatment efficacy was reviewed. Nine questions were then formulated by the ELCWP. After reviewing the literature with experts on these questions, it can be concluded that overall survival is still the best criterion for predicting treatment efficacy in lung cancer. Some intermediate criteria can be early predictors, if not surrogates, for survival, despite limitations in their potential application: these include time to progression, progression-free survival, objective response, local control after radiotherapy, downstaging in locally advanced nonsmall cell lung cancer (NSCLC), complete resection and pathological TNM in resected NSCLC, and a few circulating markers. Other criteria assessed in these recommendations are not currently adequate surrogates of survival in lung cancer.
European Respiratory Journal 07/2011; 39(1):9-28. · 5.89 Impact Factor
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M Paesmans,
J J Lafitte,
J Lecomte,
T Berghmans,
A Efremidis,
V Giner,
O Van Cutsem,
A Scherpereel,
A P Meert,
N Leclercq,
P Van Houtte,
J P Sculier
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ABSTRACT: The aim of the present study was to validate and compare published prognostic classifications for predicting the survival of patients with small cell lung cancer. We pooled data from phase III randomised clinical trials, and used Cox models for validation purposes and concordance probability estimates for assessing predictive ability. We included 693 patients. All the classifications impacted significantly on survival, with hazard ratios (HRs) in the range 1.57-1.68 (all p<0.0001). Median survival times were 16-19 months for the best predicted groups, while they were 6-7 months for the most poorly predicted groups. Most of the paired comparisons were statistically significant. We obtained similar results when restricting the analysis to patients with extensive disease. Multivariate Cox models for fitting survival data were also performed. The HRs for a single covariate were 8.23 (95% CI 5.88-11.69), and 9.46 (6.67-13.50), and for extensive disease were 5.60 (3.13-9.93), 12.49 (5.57-28.01) and 8.83 (4.66-16.64). Concordance probability estimates ranged 0.55-0.65 (overlapping confidence intervals). Published classifications were validated and suitable for use at a population level. As expected, prediction at an individual level remains problematic. A specific model designed for extensive-disease patients did not appear to perform better.
European Respiratory Journal 05/2011; 38(3):657-63. · 5.89 Impact Factor
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ABSTRACT: Few data are available about the predictive value of FDG-PET-CT in the evaluation of the response to chemotherapy of patients with advanced NSCLC and its impact on subsequent survival.
A retrospective study of patients with advanced NSCLC who underwent a FDG-PET-CT before treatment and after three cycles of first-line chemotherapy. Morphological and metabolic responses were assessed respectively using RECIST/OMS and EORTC criteria. The relation between response and survival was analysed through Cox regression models.
Fifty-nine patients were included in the study (stage IIIA/IIIB/IV: 9/11/39). Median survival was 40 weeks (44 deaths observed). The evaluation of treatment response (morphological or metabolic, taken alone or combined) in terms of survival failed to identify any difference between responders and patients with stable disease. Only patients with progressive disease had a significantly shorter survival. The negative predictive value of the metabolic response for the morphological response is 0.90 and that of metabolic progression for morphological progression is 0.98.
Only progressive disease differs significantly from other types of response with a more sensitive and earlier detection by PET-CT.
Revue des Maladies Respiratoires 05/2011; 28(5):618-25. · 0.59 Impact Factor
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A Scherpereel,
T Berghmans,
J J Lafitte,
B Colinet,
M Richez,
Y Bonduelle,
A P Meert,
X Dhalluin,
N Leclercq, M Paesmans,
L Willems,
J P Sculier
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ABSTRACT: No treatment is recommended for patients with malignant mesothelioma (MM) failing after first-line cisplatin-based chemotherapy. In vitro data suggested that valproic acid, a histone deacetylase inhibitor (HDACi), had a proapoptotic effect and synergised with doxorubicin to induce apoptosis in MM cells. Our primary end-point was to determine response rate of combined valproic acid and doxorubicin in patients with unresectable MM failing after platinum-based chemotherapy. Treatment consisted of doxorubicin (60 mg·m⁻²) plus valproic acid. An interim analysis for response rate was planned after the first 16 registered patients. All the cases were centrally reviewed. From July 2006 to March 2009, 45 eligible patients with pleural MM were registered. The majority of the patients were male (73%), had a performance status (PS) ≥ 80 (76%) and an epithelioid subtype (80%). There were seven partial responses (response rate 16%; 95% CI 3-25%), all in patients with PS 80-100. The best disease control rate was 36% (95% CI 22-51%). Two toxic deaths were observed (febrile neutropenia and cerebral thrombotic event), both in patients with poor PS (60-70). Valproic acid, an HDACi, plus doxorubicin appeared an effective chemotherapy regimen in good PS (80-100) patients with refractory or recurrent MM, for which no standard therapy was available.
European Respiratory Journal 01/2011; 37(1):129-35. · 5.89 Impact Factor
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R Herbrecht,
J Maertens,
L Baila,
M Aoun,
W Heinz,
R Martino,
S Schwartz,
A J Ullmann,
L Meert, M Paesmans,
O Marchetti,
H Akan,
L Ameye,
M Shivaprakash,
C Viscoli
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ABSTRACT: Caspofungin at standard dose was evaluated as first-line monotherapy of mycologically documented probable/proven invasive aspergillosis (IA) (unmodified European Organisation for Research and Treatment of Cancer/Mycosis Study Group criteria) in allogeneic hematopoietic SCT patients. The primary efficacy end point was complete or partial response at end of caspofungin treatment. Response at week 12, survival and safety were additional end points. Enrollment was stopped prematurely because of low accrual, with 42 enrolled and 24 eligible, giving the study a power of 85%. Transplant was from unrelated donors in 16 patients; acute or chronic GVHD was present in 15. In all, 12 patients were neutropenic (<500/microl) at baseline, 10 received steroids and 16 calcineurin inhibitors or sirolimus. Median duration of caspofungin treatment was 24 days. At the end of caspofungin therapy, 10 (42%) patients had complete or partial response (95% confidence interval: 22-63%); 1 (4%) and 12 (50%) had stable and progressing disease, respectively; one was not evaluable. At week 12, eight patients (33%) had complete or partial response. Survival rates at week 6 and 12 were 79 and 50%, respectively. No patient had a drug-related serious adverse event or discontinued because of toxicity. Caspofungin first-line therapy was effective and well tolerated in allogeneic hematopoietic SCT patients with mycologically documented IA.
Bone marrow transplantation 07/2010; 45(7):1227-33. · 3.00 Impact Factor
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C Viscoli,
R Herbrecht,
H Akan,
L Baila,
A Sonet,
A Gallamini,
A Giagounidis,
O Marchetti,
R Martino,
L Meert, M Paesmans,
L Ameye,
M Shivaprakash,
A J Ullmann,
J Maertens
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ABSTRACT: Caspofungin was evaluated as first-line monotherapy of invasive aspergillosis (IA) in patients with haematological malignancies and undergoing autologous transplants.
Adults with proven or probable IA, defined strictly according to EORTC-MSG criteria, were eligible. Those with possible IA were enrolled, but were not evaluable for efficacy unless upgraded to proven/probable disease within 7 days of registration based on investigations performed within 48 h after enrolment. Caspofungin dosage was 70 mg (day 1) followed by 50 mg/day. The primary endpoint was the proportion of patients with complete or partial response at the end of caspofungin therapy in the modified intention to treat (MITT) group; secondary endpoints were response and survival at day 84 and safety.
In the MITT group (n = 61), 75% of patients had cancer not in remission (relapsing or refractory), 85% were neutropenic at enrolment and 49% had a Karnofsky score of < or =50. At end of treatment, 1 and 19 patients had complete and partial response, respectively [success rate 33% (20/61)], 9 (15%) achieved stabilization and 31 (51%) had disease progression. One patient was not evaluable. The 6 and 12 week survival rates were 66% (40/61) and 53% (32/60), respectively. Baseline characteristics associated with survival at day 84 were an underlying disease in remission (not relapsing or refractory) and Karnofsky score. Recovery from neutropenia at the end of treatment was also significantly associated with survival. No serious drug-related adverse events or discontinuations due to drug-related adverse events were observed.
Caspofungin provided an observed response rate compatible with the null hypothesis of a true response rate of < or =35%. Underlying disease-related factors had a major impact on results.
Journal of Antimicrobial Chemotherapy 12/2009; 64(6):1274-81. · 5.07 Impact Factor
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M Moreau,
J Klastersky,
A Schwarzbold,
F Muanza,
A Georgala,
M Aoun,
A Loizidou,
M Barette,
S Costantini,
M Delmelle,
L Dubreucq,
M Vekemans,
A Ferrant,
D Bron, M Paesmans
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ABSTRACT: Chemotherapy-induced neutropenia is the most common adverse effect of chemotherapy and is often complicated by febrile neutropenia (FN). The objective of this study is to validate a classification of aggressiveness of a chemotherapy regimen and to evaluate its usefulness in a risk prediction model of FN in patients with hematological cancer at the beginning of a chemotherapy cycle.
Two hundred and sixty-six patients were prospectively enrolled and followed during 1053 cycles. Relevant patient informations were collected at the beginning of the first cycle and the number of days of FN were counted in the follow-up [dichotomized (no FN versus >or= 1 day of FN)].
Aggressive chemotherapy regimen is the major predictor of FN [odds ratio 5.2 (3.2-8.4)]. The other independent predictors are the underlying disease, an involvement of bone marrow, body surface <or= 2 m(2), a baseline monocyte count <150/microl and the interaction between the first cycle in the same treatment line and a baseline hemoglobin dosage. A rule of prediction of FN was computed with these characteristics: sensitivity 78.6%, specificity 62.3%, positive predictive value 42.7% and negative predictive value 89.1%.
Further studies are needed to validate this score.
Annals of Oncology 01/2009; 20(3):513-9. · 6.43 Impact Factor
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T Berghmans,
P Van Houtte, M Paesmans,
V Giner,
J Lecomte,
G Koumakis,
M Richez,
S Holbrechts,
M Roelandts,
A P Meert,
S Alard,
N Leclercq,
J P Sculier
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ABSTRACT: As concomitant chemoradiotherapy for stage III NSCLC is associated with survival advantage in comparison to a sequential approach, we conducted a phase III randomised study aiming to determine the best sequence and safety of chemotherapy (CT) and chemoradiotherapy (CT-RT), using a regimen with cisplatin (CDDP), gemcitabine (GEM) and vinorelbine (VNR). Unresectable stage III NSCLC patients received CDDP (60 mg/m(2)), GEM (1g/m(2), days 1 and 8) and VNR (25mg/m(2), days 1 and 8) with reduced dosage of GEM and VNR during radiotherapy (66Gy). Two cycles of CT with radiotherapy followed by two further cycles of CT alone were administered in arm A or the reverse sequence in arm B. The study was prematurely closed for poor accrual due to administrative problems. Forty-nine eligible patients were randomised. Response rates and median survival times were, respectively 57% (95% CI: 36-78%) and 17 months (95% CI: 9.3-24.6 months) in arm A and 79% (95% CI: 64-94%) and 23.9 months (95% CI: 13.3-34.5 months) in arm B (p>0.05). Chemotherapy dose-intensity was significantly reduced in arm A. Grade 3-4 oesophagitis occurred in 5 patients. One case of grade 5 radiation pneumonitis was observed. In conclusion, chemoradiotherapy with CDDP, GEM and VNR appears feasible as initial treatment or after induction chemotherapy. Consolidation chemoradiotherapy seems less toxic with a better observed response rates and survival although no valid conclusion can be drawn from the comparison of both arms.
Lung cancer (Amsterdam, Netherlands) 10/2008; 64(2):187-93. · 3.14 Impact Factor
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ABSTRACT: The objective of this study was to assess the value of superficial (intradermal) and paratumoral (above the tumor) (ID) injection of labeled colloids for imaging sentinel lymph nodes (SLN) as a rescue technique in breast cancer patients for whom deep (intraparenchymatous) and peritumoral (around the tumor) (IP) injections had failed.
We assessed data from 2 groups of women: 469 women for whom IP injections successfully visualized a SLN (IP-only) and 52 women for whom IP injections were unsuccessful and ID injection was performed (IP0-ID). Patient characteristics and SLN results were compared.
Most characteristics of the two patients series were similar. However, IP0-ID patients were on average 10years older than the IP-only patients and had more grade-III tumors. The false negative rate (FNR) for the IP0-ID patients (9/25, 23.8%) was significantly higher than for the IP-only patients (12/240, 5%; p<0.01) and for a subgroup of IP-only patients older than 50 years (8/159, 5%; p=0.009). Four of five false negatives in the IP0-ID group involved a tumor in the outer quadrants. The FNR for cases with external tumors was 33% for the IP0-ID patients, a percentage significantly higher than the corresponding values for the IP-only patients (5.8%) and for the IP-only patients older than 50 years (5.7%).
In patients with unsuccessful deep IP injections, superficial ID injections lead to a high percentage of false negative SLN conclusions, merely when tumours were located in the outer quadrants. Thus, it is recommended that patients with unsuccessful intra-parenchymatous and peritumoral injections of radiocolloids for tumors in outer quadrants undergo complete axillary dissection.
European journal of surgical oncology: the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology 07/2008; 34(6):615-9. · 2.56 Impact Factor
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V Durbecq,
L Ameye,
I Veys, M Paesmans,
C Desmedt,
N Sirtaine,
C Sotiriou,
C Bernard-Marty,
J M Nogaret,
M Piccart,
D Larsimont
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[hide abstract]
ABSTRACT: To investigate the influence of ageing on the incidence of breast cancer (BC) molecular subtypes, patient age at diagnosis was correlated with bio-pathological data collected retrospectively from 2723 consecutive patients diagnosed/treated at our Institute between 2000 and 2003.
According to their bio-characteristics, 61% of the samples could be assigned to a molecular subtype: the "HER-2+", the "ER & HER2 negative" or one of the two "luminal-like" subtypes divided according to their histological grade ("A" [HER-2-/ER+/grade 1-2] and "B" [HER-2-/ER+/grade 3]).
Age is highly influencing the incidence of BC molecular subtypes. Patients younger than 40 develop a statistically higher rate of high grade proliferating "HER-2" (27%) and "ER & HER2 negative" (31%) BC whereas patients older than 50 develop mostly less aggressive hormone-dependant "luminal-A" BC (>67%). Nevertheless, a significant proportion of patients older than 70 develop "luminal-B" (19%) tumours associated with high proliferation, high grade, large size and nodal invasion.
Critical Reviews in Oncology/Hematology 07/2008; 67(1):80-92. · 4.41 Impact Factor
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ABSTRACT: Murine double minute clone 2 (MDM2), p14 alternate reading frame (p14arf), and nucleophosmin (NPM) regulate p53 activity. A total of 200 biopsies, including normal bronchial, pre-invasive and invasive tissues, were examined for changes in NPM, p14arf, MDM2 and p53 expression patterns by immunohistochemistry and immunofluorescence with confocal microscopy. NPM and p14arf displayed a diffuse nuclear staining in most normal bronchial tissue. The fraction of biopsies displaying an increased MDM2 staining or a nucleolar relocalisation of NPM increased at mild and moderate dysplasia, respectively. Two different modifications occurred in p14arf expression, i.e. its loss or its nucleolar relocalisation, both increasing at severe dysplasia and both being associated with high MDM2 expression. In addition, the nucleolar relocalisation of p14arf was associated with that of NPM. Immunofluorescence staining indicated that NPM and p14arf either co-localised in the nucleoplasm or in the nucleoli, before and as a result of severe dysplasia, respectively. MDM2 was not detected in the nucleoli. Thus, changes occur in murine double minute clone 2, p14 alternate reading frame and nucleophosmin level of expression and/or cellular distribution during early steps of lung carcinogenesis. Their relative localisation as determined by immunofluorescence, supports the hypothesis that p14 alternate reading frame nucleolar relocalisation impairs p14 alternate reading frame-murine double minute clone 2 complex formation and that nucleophosmin might sequester p14 alternate reading frame. The demonstration of this hypothesis requires further functional studies.
European Respiratory Journal 06/2008; 32(3):678-86. · 5.89 Impact Factor
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J P Sculier,
J J Lafitte,
A Efremidis,
M C Florin,
J Lecomte,
M C Berchier,
M Richez,
T Berghmans,
A Scherpereel,
A P Meert,
G Koumakis,
N Leclercq, M Paesmans,
P Van Houtte
[show abstract]
[hide abstract]
ABSTRACT: The purpose of this study was to determine in limited small-cell lung cancer if locoregional irradiation concurrently with induction chemotherapy with cisplatin and etoposide prolongs survival when cisplatin is given daily as a radiosensitiser.
Two-hundred and four eligible patients were randomised between standard radiosensitised induction chemoradiotherapy (arm A) with cisplatin (90 mg/m(2) day 1) plus etoposide and daily radiosensitised induction chemoradiotherapy (arm B) with cisplatin (6 mg/m(2)/day) plus etoposide. Chemotherapy and chest irradiation (39.90 Gy in 15 fractions >3 weeks) both started on day 1.
There was no difference in survival between both arms with respective median, 2 and 5 years of 15.5 months, 35% and 18% in arm A and 17.0 months, 38% and 21% in arm B (P = 0.50). Performance status and T status were identified as independent prognostic factors for survival. In terms of local control rate, there was a statistical trend in favour of arm A with 2% only local relapse versus 10% in arm B. Daily cisplatin radiosensitisation was associated with more oesophagitis and thrombopenia but less nephrotoxicity.
Induction chemoradiotherapy resulted in both arms in good long-term survival, comparable to the best reported results and without improvement by daily cisplatin administration.
Annals of Oncology 05/2008; 19(10):1691-7. · 6.43 Impact Factor
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M T Genot-Klastersky,
J Klastersky,
F Awada,
A Awada,
P Crombez,
M D Martinez,
M F Jaivenois,
M Delmelle,
G Vogt,
N Meuleman, M Paesmans
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ABSTRACT: Low-energy laser (LEL) treatment has been suggested as an effective and safe method to prevent and/or treat oral mucositis induced by chemotherapy and/or radiotherapy; however, it has not gained wide acceptance so far.
We conducted two clinical trials testing the LEL technique: firstly, as a secondary prevention in patients with various solid tumors treated with chemotherapy who all developed severe mucositis after a previous identical chemotherapy and, secondly, as therapeutic intervention (compared to sham illumination in a randomized way) in patients with hematological tumors receiving intensive chemotherapy and having developed low-grade oral mucositis.
We entered 26 eligible patients in the first study and 36 were randomized in the second study. The success rate was 81% (95%CI = 61-93%) when LEL was given as a preventive treatment. In the second study, in patients with existing lesions, the therapeutic success rate was 83% (95%CI = 59-96%), which was significantly different from the success rate reached in the sham-treated patients (11%; 95%CI = 1-35%); the time to development of grade 3 mucositis was also significantly shorter in the sham-treated patients (p < 0.001).
Our results strongly support the already available literature, suggesting that LEL is an effective and safe approach to prevent or treat oral mucositis resulting from cancer chemotherapy.
Supportive Care Cancer 05/2008; 16(12):1381-7. · 2.60 Impact Factor
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J P Sculier,
J J Lafitte, M Paesmans,
J Lecomte,
C G Alexopoulos,
O Van Cutsem,
V Giner,
A Efremidis,
M C Berchier,
T Collon,
A P Meert,
A Scherpereel,
V Ninane,
G Koumakis,
M M Vaslamatzis,
N Leclercq,
T Berghmans
[show abstract]
[hide abstract]
ABSTRACT: The aim of the present study was to determine the potential benefit of conventional cisplatin-based chemotherapy on patients with advanced nonsmall cell lung cancer (NSCLC) and poor performance status (PS), defined as 60-70 on the Karnofsky scale. Retrospective analysis was carried out of a randomised trial performed in advanced NSCLC where 485 patients received three courses of gemcitabine+ifosfamide+cisplatin induction chemotherapy. Of the patients, 80% had good PS (Karnofsky 80-100) and 20% poor PS. Response rates were 38 and 28%, respectively. Clinical improvement, defined as achieving a good PS during chemotherapy, was observed overall in 25% of the poor PS patients, with rates of 38, 20 and 14%, respectively, in case of response, no change and progression. PS improved more quickly in the responders. Survival of patients with poor PS was significantly worse, but survival of responders was similar, irrespective of the initial poor or good PS. Although nonfatal toxicity was almost similar, there were more toxic deaths (including vascular and cardiac fatalities) in the poor PS patients (9.2 versus 2.1%). In conclusion, combination chemotherapy is associated with clinical improvement in a substantial number of patients with advanced nonsmall cell lung cancer of poor performance status.
European Respiratory Journal 01/2008; 30(6):1186-92. · 5.89 Impact Factor
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ABSTRACT: A total of 2142 patients with febrile neutropenia resulting from cancer chemotherapy were registered in two observational studies and followed prospectively in different institutions. There were 499 (23%) patients with bacteraemia who are reviewed here. The relative frequencies of Gram-positive, Gram-negative and polymicrobial bacteraemias were 57%, 34% and 10% with respective mortality rates of 5%, 18% and 13%. Mortality rates were significantly higher in bacteraemic patients than in non-bacteraemic patients; a trend for higher mortality was observed (without reaching statistical significance) in those patients in whom bacteraemia was associated with a clinical site of infection compared to bacteraemic patients without any clinical documentation. Prophylactic antibiotics but not granulopoiesis stimulating factors were associated with a lower incidence of Gram-negative bacteraemia; however, neither prophylactic approach influenced the subsequent rate of complications in the patients who developed bacteraemia. The present study also confirms that the MASCC scoring system can identify a group of bacteraemic patients with a relatively low risk of complications and death (MASCC >/=21). On the other hand, in patients with very low levels of the MASCC score (<15), and then with predicted very unfavourable risk, the rate of complications and death was dramatically high, irrespective of the microbiological nature of the bacteraemia.
International Journal of Antimicrobial Agents 11/2007; 30 Suppl 1:S51-9. · 4.13 Impact Factor
