Paclitaxel in combination chemotherapy with radiotherapy in patients with unresectable stage III non-small-cell lung cancer.

Greco, F. Anthony; Stroup, Steven L.; Gray, James R.; Hainsworth, John D.

doi:10.1200/jco.1996.14.5.1642

Cited by 27 publications

(19 citation statements)

References 19 publications

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“…In fact, oesophagitis, although common, was severe requiring tube feeding in only two cases. In contrast, incidence of severe oesophagitis in most recently developed concurrent chemoradiation programmes was reported as high as 45% (Greco et al, 1996). In addition, radiation pneumonitis, which has been reported as one of the most serious complications with the concurrent use of chemotherapy and radiation (Reckzeh et al, 1996) was almost absent in our study.…”

Section: Discussioncontrasting

confidence: 64%

“…However, with the exception of those regimens where concurrent chemotherapy consisted of single-agent cisplatin, most regimens using combination chemotherapy or third-generation agents concurrently with thoracic irradiation have shown severe additive toxicity, particularly oesophagitis and pneumonitis (Lee et al, 1996;Reckzeh et al, 1996;Frasci et al, 1997). Recently, there have been a number of attempts to further improve the results of combined chemoradiation by using more recently developed chemotherapy regimens and by adding sequential chemotherapy to concurrent chemoradiation in order to take possible advantage of two different chemoradiation strategies combined together (Greco et al, 1996;Choy et al, 1997;Isokangas et al, 1998). Although preliminary results have been extremely promising in terms of activity, the enhanced normal-tissue toxicity resulting from these novel chemoradiation regimens is worrying.…”

Section: Discussionmentioning

confidence: 99%

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Induction chemotherapy followed by concurrent standard radiotherapy and daily low-dose cisplatin in locally advanced non-small-cell lung cancer

et al. 1999

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Both induction chemotherapy and concurrent low-dose cisplatin have been shown to improve results of thoracic irradiation in the treatment of locally advanced non-small-cell lung cancer (NSCLC). This phase II study was designed to investigate activity and feasibility of a novel chemoradiation regimen consisting of induction chemotherapy followed by standard radiotherapy and concurrent daily low-dose cisplatin. Previously untreated patients with histologically/cytologically proven unresectable stage IIIA/B NSCLC were eligible. Induction chemotherapy consisted of vinblastine 5 mg m −2 intravenously (i.v.) on days 1, 8, 15, 22 and 29, and cisplatin 100 mg m −2 i.v. on days 1 and 22 followed by continuous radiotherapy (60 Gy in 30 fractions) given concurrently with daily cisplatin at a dose of 5 mg m −2 i.v. Thirty-two patients were enrolled. Major toxicity during induction chemotherapy was haematological: grade III–IV leukopenia was observed in 31% and grade II anaemia in 16% of the patients. The most common severe toxicity during concurrent chemoradiation consisted of grade III leukopenia (21% of the patients); grade III oesophagitis occurred in only two patients and pulmonary toxicity in one patient who died of this complication. Eighteen of 32 patients (56%, 95% CI 38–73%) had a major response (11 partial response, seven complete response). With a median follow-up of 38.4 months, the median survival was 12.5 months and the actuarial survival rates at 1, 2 and 3 years were 52%, 26% and 19% respectively. The median event-free survival was 8.3 months with a probability of 40%, 23% and 20% at 1, 2 and 3 years respectively. Induction chemotherapy followed by concurrent daily low-dose cisplatin and thoracic irradiation, in patients with locally advanced NSCLC, is active and feasible with minimal non-haematological toxicity. Long-term survival results are promising and appear to be similar to those of more toxic chemoradiation regimens, warranting further testing of this novel chemoradiation strategy. © 1999 Cancer Research Campaign

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Section: Discussioncontrasting

confidence: 64%

Section: Discussionmentioning

confidence: 99%

Induction chemotherapy followed by concurrent standard radiotherapy and daily low-dose cisplatin in locally advanced non-small-cell lung cancer

et al. 1999

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“…The use of combination chemotherapy including these new drugs has improved the survival of patients with advanced NSCLC (Giaccone et al, 1998). The feasibilities obtained with concomitant chemoradiotherapy regimens that include new agents are being reported (Greco et al, 1996;Mauer et al, 1998).…”

Section: à2mentioning

confidence: 99%

Phase I/II study of docetaxel and cisplatin with concurrent thoracic radiation therapy for locally advanced non-small-cell lung cancer

et al. 2003

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Recent studies have suggested the superiority of concomitant over sequential administration of chemotherapy and radiotherapy. Docetaxel and cisplatin have demonstrated efficacy in advanced non-small-cell lung cancer (NSCLC). This study evaluated the safety, toxicity, and antitumour activity of docetaxel/cisplatin with concurrent thoracic radiotherapy for patients with locally advanced NSCLC. Patients with locally advanced NSCLC (stage IIIA or IIIB), good performance status, age p75 years, and adequate organ function were eligible. Both docetaxel and cisplatin were given on days 1, 8, 29, and 36. Doses of docetaxel/cisplatin (mg m À2 ) in the phase I study portion were escalated as follows: 20/30, 25/30, 30/30, 30/35, 30/40, 35/40, 40/40, and 45/40. Beginning on day 1 of chemotherapy, thoracic radiotherapy was given at a total dose of 60 Gy with 2 Gy per fraction over 6 weeks. In the phase I portion, the maximum tolerated doses (MTD) among 33 patients were docetaxel 45 mg m À2 and cisplatin 40 mg m À2 . The major doselimiting toxicity (DLT) was radiation oesophagitis. The recommended doses (RDs) for the phase II study were docetaxel 40 mg m À2and cisplatin 40 mg m À2 . A total of 42 patients were entered in the phase II portion. Common toxicities were leukopenia, granulocytopenia, anaemia, and radiation oesophagitis, with frequencies of grade X3 toxicities of 71, 60, 24, and 19%, respectively. Toxicity was significant, but manageable according to the dose and schedule modifications. Dose intensities of docetaxel and cisplatin were 86 and 87%, respectively. Radiotherapy was completed without a delay in 67% of 42 patients. The overall response rate was 79% (95% confidence interval (CI), 66 -91%). The median survival time was 23.4 þ months with an overall survival rate of 76% at 1 year and 54% at 2 years. In conclusion, chemotherapy with cisplatin plus docetaxel given on days 1, 8, 29, and 36 and concurrent thoracic radiotherapy is efficacious and tolerated in patients with locally advanced NSCLC and should be evaluated in a phase III study.

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“…However, patients receiving CPT-11 chemotherapy with concurrent radiation therapy should be monitored carefully for interstitial pneumonia, as only a few patients have received this combination and few data have been accumulated so far. Approximately half the patients receiving a combination of paclitaxel, cisplatin and VP-16 and concurrent radiation therapy were reported to have experienced grade 3 or 4 oesophagitis, but this combination was feasible and highly active (Greco et al, 1996). Oesophagitis is the most common adverse effect potentiated by concurrent chemoradiotherapy.…”

Section: Discussionmentioning

confidence: 99%

Dose-finding study of irinotecan and cisplatin plus concurrent radiotherapy for unresectable stage III non-small-cell lung cancer

Yokoyama

Kurita²,

Saijo³

et al. 1998

Br J Cancer

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Summary Irinotecan hydrochloride shows marked anti-tumour activity alone and in combination with cisplatin in non-small-cell lung cancer (NSCLC). It is necessary to investigate combined-modality therapy including novel effective anti-cancer agents to improve long-term survival of patients with unresectable stage Ill NSCLC. A phase I/ll study of concurrent chemoradiotherapy with CPT-11 and cisplatin was conducted to determine the maximum tolerated dose (MTD) and efficacy in this group of patients. Thirteen previously untreated patients with unresectable stage IIIA/B NSCLC were enrolled and efficacy and toxicity was evaluated in 12 of them; one patient was ineligible. Chemotherapy was repeated every 4 weeks for three courses. Radiation therapy was started on day 2 of the first course of chemotherapy and 60 Gy in 30 fractions was given over 6 weeks. Four of six patients enrolled at level 1 completed the scheduled treatment. Another two received only one and two courses of chemotherapy as a result of persistent leucopenia and neutropenic fever respectively. Three of six patients given level 2 therapy completed the scheduled treatment. Another three received only one and two courses of chemotherapy, two refused treatment because of diarrhoea and one died of pneumonia. Radiation therapy was inadequate in these three patients. As the CPT-11 dose intensity in this trial was low, because of the necessity of omitting CPT-11 administration on days 8 and/or 15 as a result of leucopenia or diarrhoea, and the low radiation therapy completion rate, the trial was discontinued at level 2. Five patients at level 1 and three at level 2 showed partial responses, an overall response rate of 67%. Although neither MTD nor dose-limiting toxicity could be identified, chemotherapy with CPT-11 and cisplatin plus concurrent radiation therapy was deemed unacceptable. We are now conducting a phase I/Il study of chemotherapy using CPT-11 as a single agent in combination with radiation therapy.Keywords: non-small-cell lung cancer; irinotecan; radiation therapy; combined-modality therapy Approximately 25-30% of non-small cell lung cancer (NSCLC) is already unresectable stage III disease by the time it is diagnosed and, therefore, about 7000 such patients are seen in Japan per year. Traditionally, the standard treatment is radiation therapy, but the 5-year survival rate is 10% or less in patients treated with radiation therapy alone and the majority of patients experience extrathoracic recurrence (Perez et al, 1987). It is important to control distant metastases, as well as local tumours, in order to improve long-term survival. The efficacy of chemotherapy in such patients has long been a controversial issue. Recently, several randomized trials (Dillman et al, 1990(Dillman et al, , 1996Le Chevalier et al, 1991;Sause et al, 1995) and meta-analysis (Non-small Cell Lung Cancer Collaborative Group, 1995) showed that chemotherapy followed by radiation therapy was more effective than radiation therapy alone. However, survival was still only prolonged...

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Paclitaxel in combination chemotherapy with radiotherapy in patients with unresectable stage III non-small-cell lung cancer.

Cited by 27 publications

References 19 publications

Induction chemotherapy followed by concurrent standard radiotherapy and daily low-dose cisplatin in locally advanced non-small-cell lung cancer

Induction chemotherapy followed by concurrent standard radiotherapy and daily low-dose cisplatin in locally advanced non-small-cell lung cancer

Phase I/II study of docetaxel and cisplatin with concurrent thoracic radiation therapy for locally advanced non-small-cell lung cancer

Dose-finding study of irinotecan and cisplatin plus concurrent radiotherapy for unresectable stage III non-small-cell lung cancer

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