Phase I trial of docetaxel administered by weekly infusion in patients with advanced refractory cancer.

Hainsworth, John D.; Burris, Howard A.; Erland, Joan B.; Thomas, Michael; Greco, F. Anthony

doi:10.1200/jco.1998.16.6.2164

Cited by 235 publications

(114 citation statements)

References 10 publications

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“…Asthenia was the predominant side effect. This finding corresponds with published data on protocols based on weekly infusions of docetaxel (Hainsworth et al, 1998).…”

Section: Discussionsupporting

confidence: 91%

“…After this high complication rate became evident, the protocol committee decided to amend the protocol. The amendment took into account the dose intensity reached with 3-weekly irinotecan plus docetaxel as well as previously published data indicating a more favourable haematological toxicity profile, if both docetaxel and irinotecan were given in weekly schedules (Hainsworth et al, 1998;Murren et al, 2001). Indeed, with the administration of irinotecan plus docetaxel 3 out of 4 weeks, a dramatic decrease in myelosuppression was noted in comparison to the initial schedule.…”

Section: Discussionmentioning

confidence: 99%

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Phase II trial of irinotecan plus docetaxel in cisplatin-pretreated relapsed or refractory oesophageal cancer

et al. 2003

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This phase II trial assessed the toxicity and efficacy of irinotecan plus docetaxel in cisplatin-pretreated oesophageal cancer. Irinotecan 160 mg m À2 plus docetaxel 65 mg m À2 once every 3 weeks led to severe myelosuppression in four patients, all of whom experienced neutropenic fever. After amendment of this regimen, 24 patients (male/female ¼ 18/6; median age ¼ 58.5 years; ECOG performance status 0/1/2 ¼ 9/11/4) with advanced oesophageal cancer (adenocarcinoma/epidermoid carcinoma ¼ 13/11) received irinotecan 55 mg m À2 plus docetaxel 25 mg m À2 on days 1, 8 and 15 of a 28-day cycle. Serious adverse events occurred in five patients, one with lethal outcome (pneumonia). Haematological toxicity X31 was rare, whereas nonhaematological toxicity X31 was noted in nine out of 24 patients (asthenia in five patients, diarrhoea in three patients, nausea/emesis in two patients, constipation in one patient). Median survival time was 26 (range 2 -70) weeks. Response rate, assessed according to the WHO criteria, was 12.5% (95% CI 2.7 -32.4%); rate of disease stabilisation (partial remission and stable disease) was 33.3% (95% CI 15.6 -55.3%) with a median duration of 18.5 (range 16 -51) weeks. Although the nonhaematological toxicity proved to be considerable, weekly irinotecan plus docetaxel is feasible and shows some activity in extensively pretreated patients with oesophageal cancer. British Journal of Cancer (2003) Owing to early lymphogenic and haematogenous spread, most patients with oesophageal cancer are diagnosed with advanced disease. These patients receive multimodal treatment if the tumour is deemed to be resectable, or systemic chemotherapy if palliation is the goal. Cisplatin has been the mainstay of chemotherapy and chemoradiotherapy protocols during the last decade (Herskovic et al, 1992;Bleiberg et al, 1997). In case of resistance to cisplatin-based therapy, no evidence-based recommendations regarding second-line treatment exist, but many patients ask for more than measures of best supportive care. Thus, there is a need for tolerable and active protocols beyond cisplatin-based therapy. Irinotecan and taxanes proved to induce remissions in oesophageal cancer (Ilson et al, 1998(Ilson et al, , 1999 although single-agent docetaxel revealed only moderate activity (Heath et al, 2002). The combination of irinotecan and docetaxel has been investigated in phase I studies in patients with pretreated solid tumours (Adjei et al, 2000;Couteau et al, 2000). The recommended phase II dose on this schedule was irinotecan 160 mg m À2 followed by docetaxel 65 mg m À2 administered every 3 weeks (Adjei et al, 2000). This phase II trial was designed to assess the activity and toxicity of the combination of irinotecan plus docetaxel in cisplatin-pretreated relapsed or refractory oesophageal cancer. METHODS Patient populationPatients with histologically confirmed adenocarcinoma or epidermoid carcinoma of the oesophagus were enrolled at a single site (Klinikum rechts der Isar, Technical University of Munich). Eligible patients with...

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“…Asthenia was the predominant side effect. This finding corresponds with published data on protocols based on weekly infusions of docetaxel (Hainsworth et al, 1998).…”

Section: Discussionsupporting

confidence: 91%

Section: Discussionmentioning

confidence: 99%

Phase II trial of irinotecan plus docetaxel in cisplatin-pretreated relapsed or refractory oesophageal cancer

et al. 2003

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“…Weekly scheduling of docetaxel (Hainsworth et al, 1998) might remarkably reduce myelotoxicity in pretreated NSCLC patients (Lilenbaum et al, 2001), without decreasing antitumoral activity. We performed a multicentre randomised clinical trial to compare a weekly schedule of docetaxel against the standard 3-week regimen in terms of quality of life (QoL), toxicity and efficacy.…”

mentioning

confidence: 99%

A randomised clinical trial of two docetaxel regimens (weekly vs 3 week) in the second-line treatment of non-small-cell lung cancer. The DISTAL 01 study

Gridelli

Gallo²,

Maïo³

et al. 2004

Br J Cancer

147

109

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Docetaxel (75 mg m À2 3-weekly) is standard second-line treatment in advanced non-small-cell lung cancer (NSCLC) with significant toxicity. To verify whether a weekly schedule (33.3 mg m À2 for 6 weeks) improved quality of life (QoL), a phase III study was performed with 220 advanced NSCLC patients, p75 years, ECOG PS p2. QoL was assessed by EORTC questionnaires and the Daily Diary Card (DDC). No difference was found in global QoL scores at 3 weeks. Pain, cough and hair loss significantly favoured the weekly schedule, while diarrhoea was worse. DDC analysis showed that loss of appetite and overall condition were significantly worse in the 3-week arm in the first week, while nausea and loss of appetite were more severe in the weekly arm in the third week. Response rate and survival were similar, hazard ratio of death in the weekly arm being 1.04 (95% CI 0.77 -1.39). A 3-weekly docetaxel was more toxic for leukopenia, neutropenia, febrile neutropenia and hair loss; any grade 3 -4 haematologic toxicity was significantly more frequent in the standard arm (25 vs 6%). The weekly schedule could be preferred for patients candidate to receive docetaxel as second-line treatment for advanced NSCLC, because of some QoL advantages, lower toxicity and no evidence of strikingly different effect on survival.

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“…Thus, the weekly schedule of docetaxel improved hematologic and nonhematologic toxicities compared with an every-3-week regimen, without modifying the response rate in HRPC. 18,34 Conversely, the combination of docetaxel with estramustine significantly improved biological response and survival. Nevertheless, this combination led to adverse effects that were clearly related to estramustine.…”

Section: Discussionmentioning

confidence: 99%

Phase II trial evaluating a docetaxel‐capecitabine combination as treatment for hormone‐refractory prostate cancer

Ferrero

Chamorey

Oudard

et al. 2006

Cancer

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Food is well‐known to encode social and cultural values, for example different social groups use different consumption patterns to act as social boundaries. When societies and cultures change, whether through drift, through population replacement or other factors, diet may also alter despite unchanging resource availability within a region. This study investigates the extent to which dietary change coincides with cultural change, to understand the effects of large‐scale migrations on the populations' diets. Through stable carbon and nitrogen isotope analysis of Iron Age, Roman, and Early Medieval human bone collagen, we show that in Croatia large‐scale cultural change led to significant changes in diet. The isotopic evidence indicates that Iron Age diet consisted of C3 foodstuffs with no isotopic evidence for the consumption of C4 or marine resources. With the Roman conquest, marine resources were added to the diet, although C3 foodstuffs continued to play an important role. In the Early Medieval period, this marine component was lost and varying amounts of C4 foodstuffs, probably millet, were added to the otherwise C3 diet. In both of these transitions it is likely that the changes in diet are related to the arrival of a new people into the area. Am J Phys Anthropol 2012. © 2012 Wiley Periodicals, Inc.

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Phase I trial of docetaxel administered by weekly infusion in patients with advanced refractory cancer.

Cited by 235 publications

References 10 publications

Phase II trial of irinotecan plus docetaxel in cisplatin-pretreated relapsed or refractory oesophageal cancer

Phase II trial of irinotecan plus docetaxel in cisplatin-pretreated relapsed or refractory oesophageal cancer

A randomised clinical trial of two docetaxel regimens (weekly vs 3 week) in the second-line treatment of non-small-cell lung cancer. The DISTAL 01 study

Phase II trial evaluating a docetaxel‐capecitabine combination as treatment for hormone‐refractory prostate cancer

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