Activity of gemcltabine in metastatic breast cancer (MBC) patients previously treated with anthracycline-containlng regimens

Spielmann, M.; Kalla, S.; Liombart-Cussac, A.; Espié, M.; Namer, M.; Ferrero, Jean-­Marc; Cuvier, C.; Fumoleau, P.; Ponzio, Anne; Kayitalire, L.; Pouillart, P

doi:10.1016/s0959-8049(97)85243-4

Cited by 29 publications

(14 citation statements)

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“…Median time to response and survival were 1.9 and 11.5 months, respectively. Similar results were reported with higher doses of gemcitabine in two other phase II studies on metastatic breast cancer (Blackstein et al, 1997;Spielmann et al, 1997). In particular, Spielmann et al (1997) evaluated 43 women previously treated with anthracyclines and achieved an ORR of 28% (95% CI 15 -44%), with a dose of 1200 mg m À2 given at the same schedule as above.…”

Section: Discussionsupporting

confidence: 68%

“…Similar results were reported with higher doses of gemcitabine in two other phase II studies on metastatic breast cancer (Blackstein et al, 1997;Spielmann et al, 1997). In particular, Spielmann et al (1997) evaluated 43 women previously treated with anthracyclines and achieved an ORR of 28% (95% CI 15 -44%), with a dose of 1200 mg m À2 given at the same schedule as above. More recently, with a lower dosage (1000 mg m À2 ) and the same schedule, Possinger et al (1999) reported a 14.3% response, with minimal toxicity, in 42 not previously treated patients with prevalent visceral disease.…”

Section: Discussionsupporting

confidence: 68%

“…In particular, in metastatic breast cancer, gemcitabine alone yielded response rates of 25 -46% in the first phase II studies (Hertel et al, 1990;Carmichael et al, 1995;Blackstein et al, 1997;Spielmann et al, 1997;Possinger et al, 1999). Haematological and nonhaematological side effects were mild, with dose reductions, treatment delays or withdrawals only seldom reported.…”

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confidence: 99%

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Phase I/II study of gemcitabine plus mitoxantrone as salvage chemotherapy in metastatic breast cancer

Lorusso¹,

Crucitta²,

Silvestris³

et al. 2003

Br J Cancer

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The purpose of this study was to determine the maximum-tolerated dose of gemcitabine plus mitoxantrone in women with metastatic breast cancer (MBC) and to evaluate activity and toxicity of this combination in a phase II trial. Sixty-three patients with MBC, previously treated with chemotherapy including anthracycline and/or taxanes, were treated with mitoxantrone 10 or 12 mg m À2 intravenously on day 1 plus gemcitabine in escalating doses from 600 to 1200 mg m À2 intravenously on days 1 and 8, every 3 weeks. In phase I, on 23 patients entered on study, dose-limiting toxicity occurred at the dosage of 1200 mg m À2 gemcitabine and 10 mg m À2 mitoxantrone, with three out of five patients developing grade 4 neutropenia. In phase II, with gemcitabine administered at 1000 mg m À2 and mitoxantrone at 10 mg m À2 , 12 (30%) out of 40 assessable patients responded, even if no complete response was obtained. Moreover, stable disease was observed in eight (20%) patients. The median time to treatment failure was 22 weeks (range, 2 -33), and median survival was 42 weeks (range, 2 -92). Grade 3 and 4 neutropenia were observed in 12 (30%) and one (2.5%) cases respectively; grade 3 thrombocytopenia was observed in two patients (5%), grade 2 mucositis in two patients (5%), grade 3 anaemia in two patients (5%), grade 3 alopecia in one patient (2.5%) and asymptomatic cardiotoxicity in three patients (8%), respectively. In conclusion, the doses of 10 mg m À2 (day 1) for mitoxantrone and 1000 mg m À2 for gemcitabine (days 1 -8) every 3 weeks resulted active and safe in MBC. Further investigations in less heavily pretreated patients are warranted.

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Section: Discussionsupporting

confidence: 68%

Section: Discussionsupporting

confidence: 68%

mentioning

confidence: 99%

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Phase I/II study of gemcitabine plus mitoxantrone as salvage chemotherapy in metastatic breast cancer

Lorusso¹,

Crucitta²,

Silvestris³

et al. 2003

Br J Cancer

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“…In view of the variability in response rates, further studies were performed in breast cancer patients. A study was performed in patients previously treated with anthracyclines (Spielmann et al, 1996). All patients had responded to anthracycline treatment for metastatic breast cancer for at least 6 months.…”

Section: Breast Cancermentioning

confidence: 99%

The role of gemcitabine in the treatment of other tumours

Carmichael

1998

Br J Cancer

109

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Summary Gemcitabine (GEMZARO) is a novel nucleoside analogue with activity in a range of preclinical models both in vitro and in vivo. It is highly schedule dependent, with weekly x3 every 4 weeks being the recommended schedule for phase 11/111 studies. Early phase 11 trials identified activity against non-small-cell lung cancer and pancreatic cancers, tumour types for which gemcitabine has a licence for treatment in many countries. However, the preclinical models indicated that gemcitabine may be active against many other human solid tumours. In phase 11 studies, activity has been identified against breast cancer, both as a single agent and in combination. In bladder cancer, impressive single-agent activity of gemcitabine has also been seen, as well as in combination with cisplatin, initially in MVAC and platinum failures but more recently as first-line therapy both as a single agent and combined with cisplatin. Anti-tumour activity has also been seen in patients with ovarian cancer, head and neck cancer, small-cell lung cancer and cervical cancer, with minimal activity in renal carcinoma, prostate and colon cancer. In view of the excellent side-effect profile and the potential for gemcitabine to inhibit DNA repair after exposure to DNA-damaging agents, further developments of gemcitabine will include its use in combination chemotherapy and combined modality schedules.

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“…Based on pre-clinical evidence of a potentially favourable interaction between paclitaxel and gemcitabine (Kroep et al, 1999), as well as encouraging activity for gemcitabine in advanced breast cancer (Carmichael et al, 1995;Blackstein et al, 1997;Spielmann et al, 1997;Sanchez et al, 1998;Akrivakis et al, 1999;Colomer et al, 2000), the tAnGo trial was initiated in the year 2000 to test the addition of gemcitabine to block sequential anthracycline and paclitaxel adjuvant chemotherapy. The trial compared EC-GT (four cycles of epirubicin 90 mg m À2 and cyclophosphamide 600 mg m À2 day 1 every (q) 3 weeks, followed by four cycles of paclitaxel 175 mg m À2 every 3 h infusion day 1 and gemcitabine 1250 mg m À2 days 1 and 8 q3 weeks) with EC-T.…”

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confidence: 99%

tAnGo: a randomised phase III trial of gemcitabine in paclitaxel-containing, epirubicin/cyclophosphamide-based, adjuvant chemotherapy for early breast cancer: a prospective pulmonary, cardiac and hepatic function evaluation

et al. 2008

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tAnGo is a large randomised trial assessing the addition of gemcitabine(G) to paclitaxel(T), following epirubicin(E) and cyclophosphamide(C) in women with invasive higher risk early breast cancer. To assess the safety and tolerability of adding G, a detailed safety substudy was undertaken. A total of 135 patients had cardiac, pulmonary and hepatic function assessed at (i) randomisation, (ii) mid-chemotherapy, (iii) immediately post-chemotherapy and (iv) 6 months post-chemotherapy. Skin toxicity was assessed during radiotherapy. No differences were detected in FEV 1 or FVC levels between treatment arms or time points. Diffusion capacity (TL CO ) reduced during treatment (Po0.0001), with a significantly lower drop in EC-GT patients (P ¼ 0.02). Most of the reduction occurred during EC and recovered by 6-months post treatment. There was no difference in cardiac function between treatment arms. Only 11 patients had echocardiography/MUGA results change from normal to abnormal during treatment, with only five having LVEFo50%. Transient transaminitis occurred in both treatment arms with significantly more in EC-GT patients postchemotherapy (AST P ¼ 0.03, ALT P ¼ 0.003), although the majority was low grade. There was no correlation between transaminitis and other toxicities. Both treatment regimens reported temporary reductions in pulmonary functions and transient transaminitis levels. Despite these being greater with EC-GT, both regimens appear well tolerated.

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Activity of gemcltabine in metastatic breast cancer (MBC) patients previously treated with anthracycline-containlng regimens

Cited by 29 publications

References 0 publications

Phase I/II study of gemcitabine plus mitoxantrone as salvage chemotherapy in metastatic breast cancer

Phase I/II study of gemcitabine plus mitoxantrone as salvage chemotherapy in metastatic breast cancer

The role of gemcitabine in the treatment of other tumours

tAnGo: a randomised phase III trial of gemcitabine in paclitaxel-containing, epirubicin/cyclophosphamide-based, adjuvant chemotherapy for early breast cancer: a prospective pulmonary, cardiac and hepatic function evaluation

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