Intravesical gemcitabine (G) single
agent as adjuvant chemotherapy in superficial transitional cell
carcinoma (TCC) of bladder.
2004 - Abstract n° 4061
K. Bouzid, R. Ferhat, A. Bounedjar,
H. Mahfouf, F. Smaili, K. Adjali
EHS Pierre&Marie Curie Center, Algiers, Algeria - CAC Blida, Blida,
Algeria - CHU Bab el Oued, Algiers, Algeria
Background : Intravesical G (2000
mg twice weekly) has been shown in a phase I study to be a safe
regimen in bacillus Calmette-Guerin (BCG) refractory TCC (Dalbagni
G et al. J Clin Oncol. 2002; 20: 3193-3198). The objectives of this
trial were to evaluate the toxicity and efficacy of intravesical
G as adjuvant chemotherapy in patients (pts) with superficial TCC
of the bladder.
Methods : Chemonaive pts with histological
diagnosis of TCC confirmed by total (ultrasonographic control) transurethral
resection (TUR) received intravesical G 2000 mg/week diluted (inbuffered)
in 100 ml of saline solution once weekly for 6 weeks. After Total
TUR and three weeks of rest, they received 2000 mg G once a week
for 6 weeks. Additional inclusion criteria were: age > 18 yrs, PS
= 1, adequate hematologic, hepatic and renal function, and written
informed consent. Toxicity was evaluated at every intravesical administartion.
Efficacy was evaluated three months after the end of treatment by
ultrasonography, cytology, and TUR with bladder biopsy.
Results : Twenty-nine pts (28 male,
1 female), recruited in two centers were enrolled in this study.
There were 9 pts with carcinoma in situ and 20 pts with pT1 lesions.
The median age was 60 yrs (range 24-83). After 348 total instillations
(6 months of treatment), 29 pts were evaluable for toxicity in WHO
scale. Nonhematological toxicities were grade 1: irritative bladder
reaction (7,4%) , asthenia (4,8%) , nausea (1%) hot flashes (4%).
Grade 1 hematologic toxicities were anemia (9%), leucopenia (8%)
and thrombocytopenia ( 0,5% ) 2 pts. after a median follow-up time
of 12 months ( range 3-15 months), all 29 pts were in complete remission
without superficial bladder carcinoma-related events.
Conclusions : G as adjuvant intravesical
chemotherapy in superficial TCC of the bladder is safe , with minimal
toxicity even after repeated instillations. Preliminary results
of efficacy appears to be favorable.
A retrospective analysis to evaluate
adjuvant chemotherapy after radical surgery on survival and disease
recurrence in patients with stage I, II, IIIA non-small cell lung
2004 - Abstract n° 7360
M. Gamaz, S. Ameur, H. Chaouche,
EHS P&M Curie CPMC, Algiers, Algeria - CHU Mustapha, Algiers, Algeria
Background : Adjuvant chemotherapy
has become a standard treatment in patients (pts) with NSCLC who
have had carcinologic resection (Le Chevalier, ASCO 2003, abstr
6). The aim of this retrospective study was to analyze the outcome,
in terms of survival and disease recurrence, of pts with NSCLC who
received adjuvant chemotherapy after radical surgery.
Methods : Inclusion criteria: histologically
proven NSCLC stage I-IIIA treated with carcinologic surgery, PS
=1, and adequate hematologic, hepatic, and renal function. Twenty-eight
(28) pts (all males) were reviewed.
Results : Data were pooled and
analyzed for 28 male pts with a median age of 54.4 years (range,
47-71 years). Stage IB, IIB, and IIIA disease was noted in 7, 5,
and 16 pts, respectively. Histologic types were adenocarcinoma (n=11)
and squamous cell carcinoma (n=17). Pts underwent the following
surgical procedures: lobectomy (n=10), bilobectomy (n=3), and pneumonectomy
(n=15). The median duration between the surgery and the onset of
adjuvant chemotherapy was six weeks (range, 3-7 weeks). Adjuvant
chemotherapy consisted of four cycles of cisplatin (75 mg/m2 d1)
combined with vinblastine (6 mg/m2 d1) in 2 pts, vindesine (4 mg/m2
d1) in 5 pts, etoposide (150 mg/m2 d1) in 7 pts, and gemcitabine
(1250 mg/m2 over 30 min d1,8) in 14 pts. Eleven pts (with p N1 disease)
received locoregional radiotherapy six weeks after the fourth cycle
of chemotherapy. After a median follow-up time of 28 months (range,
12-44 months), the median survival was 18 months (range, 6-43+ months).
The median free survival time was 16 months (range, 3-40+ months).
The one-year recurrence rate was 16% while the second- and third-year
rates were 5% each. The three-year survival rate was 22%.
Conclusions : The results of this
retrospective analysis confirm the importance of adjuvant chemotherapy
in NSCLC after carcinologic resection.
Gemcitabine (G) and Doxorubicin (DXR)
as first-line treatment of metastatic breast cancer (MBC) : Preliminary
2004 - Abstract n° 762
A. Bensalem, K. Bouzid
Medical Oncology, Constantine, Algeria - Medical Oncology, Algiers,
Background : G has demonstrated
efficacy in a variety of solid tumors, including breast cancer.
Forty to 50% of chemonaive patients (pts) with MBC achieve an objective
regression after monochemotherapy with anthracyclines. This study
evaluated the response rate and toxicity of G and DXR in non-pretreated
pts with MBC.
Methods : Chemonaive women aged
between 18-75 years; an ECOG performance status (PS) 0-2; histologically
or cytologically proven diagnosis of mammary carcinoma; adequate
bone marrow reserve, renal and hepatic function; measurable disease;
and written consent received G 1250 mg/m² and DXR 25 mg/m² on days
1,8, every 3 weeks.
Results : To date, 19 pts with
a median age of 42.9 years (range, 31-56) have been enrolled. Fifteen
pts (78.9%) had PS 1. All pts had visceral disease: two with 3 localizations
(bone, liver, lung); twelve with 2 localizations (bone, liver);
and five with diffuse bone metastases. Pts received a median of
3 cycles (range, 2-4). Preliminary efficacy and safety data are
available for 13 pts. So far, 9 objective responses (7 complete
responses, 2 partial responses) with a rate of 69%, 3 stable disease
and 1 progressive disease have been confirmed. Three of the 5 evaluable
pts with liver metastasis responded completely after 4 cycles and
were evaluated 1 month after the fourth cycle by CT scan. Nonhematologic
WHO toxicity included grade 4 cutaneous in 1 pt (second cycle),
grade 3 alopecia in 14 pts, and grade 1 nausea/vomiting in 6 pts.
Hematologic toxicity were grade 2 neutropenia in 5 pts, grade 2
anemia in 3 pts, and grade 2 thrombocytopenia in 2 pts.
Conclusions : This regimen seems
to be well tolerated and active outpatient therapy for the treatment
of metastatic breast cancer.
Gemcitabine (G) plus cisplatin (C) plus
radiotherapy in first-line treatment of locally advanced and metastatic
undifferentiated carcinoma of the nasopharyngeal type (UCNT) : Preliminary
results of a phase II study
2004 - Abstract n° 5618
S. Adane, M. Sadouki, F. Mekki,
Ain-Naadja Universitary Hospital, Algiers, Algeria - P&M Curie Center,
Background : In our experience,
G is efficient (44%) in third-line monotherapy of recurrent metastatic
nasopharynx carcinoma after first-line 5-fluorouracil + C and second-line
anthracyclines + taxanes (ASCO 2002 abstract #3034). In this prospective,
phase II study, we used G + C in neoadjuvant setting before radiotherapy
in first-line treatment of patients (pts) with locally advanced
and metastatic UCNT. The primary endpoint was toxicity and the secondary
endpoints of this study included objective response and pathological
Methods : Chemonaive pts with histologically
(WHO type 3) proven stage III and IV TNM/UICC 1997, and an ECOG
performance status (PS) 0-2 received G 1250 mg/m² over a 30-minute
infusion on days (D) 1 and 8 and C 70 mg/m² on D1, every 3 weeks.
Four to 6 weeks after the third cycle of induction chemotherapy,
curative intent radiotherapy was given on nasopharynx (70-72 Gys)
and on cervical nodes (50 Gys). Four weeks after radiotherapy, 2
cycles of G + C were given. Follow-up was performed 4 weeks after
the third cycle by clinical evaluation, CT scan of nasopharynx,
and nasofibroscopy with biopsy.
Results : To date, 12 pts (11 men)
with a median age of 45 years (range 22-65) and a PS 0 (2 pts),
PS 1 (7 pts) and PS 2 (2 pts) have been enrolled. Seven pts had
stage IVA, 3 pts had stage IVC, and 2 pts had stage III. A total
of 43 cycles have been completed with a median of 3.6 cycles (range
2-4). All pts were evaluable for toxicity. No WHO grade 3/4 toxicity
occurred. The most commonly reported hematologic event was grade
2 neutropenia (4%) and thrombocytopenia (2%). The most common nonhematologic
event was grade 2 asthenia (12%) and nausea/vomiting (9%) Of the
10 patients evaluable for response, there were 5 complete response
(all pathological complete response with 50% pf pCR) and 3 partial
responses for an overall response rate of 80%. One pt reported stable
disease, and 1 progressed.
Conclusions : Based on this preliminary
results, G + C appears to be very effective and well tolerated for
chemonaive pts with UCNT.
A phase II trial of docetaxel and cisplatin
combination in patients with locally advanced undifferentiated carcinoma
of nasopharygeal type (UCNT)
2004 - Abstract n° 5599
M. Yamouni, Y. Beldjillali, K.
A. Benhadji, I. Lahfa, M. Brahimi, M. Ait-Said, L. Djellali, K.
CHU Oran, Department of Medical Oncology, Oran, Algeria - Aventis
Pharma, Algiers, Algeria - Centre P &M Curie, Dept of Medical Oncology,
Background : The standard treatment
of locally advanced UCNT is chemotherapy followed by locoregional
radiotherapy. The purpose of this study is to assess the antitumor
activity and toxicity of a new neoadjuvant chemotherapy regimen
combining docetaxel (D) and cisplatin (C).
Patients and Methods : Previously
untreated patients (pts) with histologically diagnosed locally advanced
UCNT (Stages IVA and IVB TNM/UICC 1997) received D 75 mg/m2 and
C 75 mg/m2 both on day 1, cycles were repeated every 21 days. Every
pts received three cycles in a neoadjuvant setting before radiotherapy
(4 to 6 weeks after the third cycle of DC). Pts were evaluated by
clinical examination, nasofibroscopy with biopsy and CT scan of
Results : Toxicity, tumor response
and survival over one year were assessable in all pts. There are
75 pts (54 male, 21 female) with a median age of 41 years (range
18 - 69) and a WHO performance status of 0 - 1 in 71 pts, 2 in 4
pts. 19 pts had stage IVA and 56 pts had stage IVB. After 225 cycles,
grade 3 & 4 toxicity (WHO) were: neutropenia (12 %), febrile neutropenia
(2%), anemia (1%), nausea and vomiting (23%), diarrhea (8%), mucositis
(1%), reversible alopecia (70%). Two pts had onycolysis. Response
rates for the 75 pts were: complete pathologic response 37 % (28
pts), partial response 52% (39 pts), stable disease 8% (6 pts) and
progression 3% (2 pts) . The overall response rate (ORR) was 89%.
72 pts had complete response after radiotherapy and one patient
had stable disease. 18 patients had recurence: 16 locoregional,
1 hepatic metastasis and 1 cerebral metastasis. Disease free survival
and overall survival at 1 year were respectively 76 % and 85 % and
the median survival was 19 months. The complete response after chemotherapy
appear as an important factor predicting recurrence.
Conclusion : DC is an effective
regimen with an acceptable safety profile in locally advanced UCNT.