Japanese Journal of Clinical Oncology Advance Access originally published online on November 22, 2005
Japanese Journal of Clinical Oncology 2005 35(12):700-706; doi:10.1093/jjco/hyi191
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© 2005 Foundation for Promotion of Cancer Research
Phase II Randomized Trial of Tri-weekly Versus Days 1 and 8 Weekly Docetaxel as a Second-line Treatment of Advanced Non-small Cell Lung Cancer
1 Pulmonary Section, Department of Internal Medicine, Buddhist Dalin Tzu Chi General Hospital, Chiayi and Buddhist Tzu Chi University, Hualien, 2 Section of Thoracic Oncology, Chest Department, Taipei Veterans General Hospital, Taipei, Taiwan, 3 School of Medicine, National Yang-Ming University, Taipei, Taiwan, and 4 Chest Department, Taipei Veterans General Hospital, Taipei, Taiwan
For reprints and all correspondence: Chun-Ming Tsai, Section of Thoracic Oncology, Chest Department of Taipei Veterans General Hospital, Shih-Pai, Taipei 11217, Taiwan. E-mail: cmtsai{at}vghtpe.gov.tw
Received June 21, 2005; accepted October 9, 2005
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Abstract |
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Background: For orientals, titrating doses of docetaxel (60–66 mg/m2) have shown equal effectiveness and fewer side effects as a second-line chemotherapy for patients with advanced non-small cell lung cancer (NSCLC). Under such doses, there were no comparative data between classic tri-weekly and Days 1 and 8 weekly schedules.
Methods: This Phase II randomized prospective study was designed to compare the toxicity profile, efficacy and quality-of-life (QOL) between these two schedules of docetaxel in the treatment of previously treated patients with advanced NSCLC. Fifty patients were randomized to docetaxel arm A (66 mg/m2 Day 1) and B (33 mg/m2 Days 1 and 8) given every 3 weeks.
Results: The overall response rates (ORRs) were 12 and 24% in arm A and B, respectively (P = 0.46), and disease control rates were 52 and 48%. The median time-to-progression (TTP) was 11.3 and 12.7 weeks and median survivals were 33.4 and 27.6 weeks, respectively. Both arms have same 1 year (36%) and 2 year survivals (12%). Arm A had significantly higher neutropenia but less compromised QOL. In this study, the response of second-line chemotherapy was significantly better in the group that was response to front-line chemotherapy (P = 0.032).
Conclusions: While Days 1 and 8 weekly docetaxel schedules show higher ORR and less hematological toxicity, there is no advantage to tri-week schedule in terms of TTP and survival, but more compromised QOL.
Key Words: chemotherapy • Days 1 and 8 weekly administration • docetaxel • non-small cell lung cancer • tri-weekly administration
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INTRODUCTION |
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Lung cancer has been the leading cause of cancer death in industrialized countries with a 5 year survival rate of only 15% (1). Non-small cell lung cancer (NSCLC) accounts for
80% of all diagnosed lung cancer patients. More than 70% of NSCLC are in advanced stages, which are not suitable for surgery alone and thus need radiotherapy, chemotherapy or multimodality management. A large meta-analysis of 52 randomized clinical trials has shown that platinum-based combination of chemotherapy outweighed best supportive care alone in patients with advanced stages of NSCLC (2). Since 1990s, newer and more active chemotherapy drugs have become available. Using these agents in combination with platinum as a front-line chemotherapy, reported randomized trials have shown consistent overall response rates (ORRs) from 30 to 40% and 1 year survival rates from 35 to 40% in addition to improvement in quality-of-life (QOL) (3–5). Nevertheless, most of the patients will eventually have disease progression after initial response. This makes the choice of second-line regimen an important but unsettled issue.
Despite that the question of non-cross-resistance between the newer agents and platinum has not been fully elucidated, the taxanes exhibit potential roles because of different mechanisms of action and resistance (6). Two multicenter randomized trials have shown promising data on docetaxel (Taxotere; Aventis Pharma, Bridgewater, NJ, USA) in the second-line treatment of NSCLC (7,8). In a recent review of second-line chemotherapy in NSCLC by Huisman et al. (9), docetaxel is the only agent that shows consistent results associated with significant benefits of 1 year survival, response rate, time-to-progression (TTP) and QOL. In an updated guideline for treatment of unresectable NSCLC by American Society of Clinical Oncology, docetaxel is the drug recommended as a second-line therapy for patients with advanced NSCLC under adequate performance status (10). The classical docetaxel schedules in these studies were 75–100 mg/m2 as 1 h infusion every 21 days (tri-weekly), whereas other Phases I and II studies have shown that docetaxel given on Days 1 and 8 weekly every 3 weeks with a divided dose of 35–40 mg/m2 is as efficacious as tri-weekly administration and has the benefit of less toxicity (11).
The rationales for weekly administration of taxanes include the evidences of schedule-dependent activity that modest concentrations should be as effective as higher concentrations and longer durations of paclitaxel exposure result in an increase in the chemosensitivity (12,13); reducing the interval between treatments should minimize the appearance of drug-resistant cell clones and regrowth, providing a greater opportunity for log tumor cell kill; furthermore, markedly less myelosuppression due to lower peak plasma concentration, supposed higher dose intensity and higher efficacy.
For orientals, the standard dose of docetaxel has been disclosed of more toxicity (14,15) and titrating doses to 60 mg/m2 have shown equal effectiveness and less side effects (16,17). In Taiwan, with a range of 10% escalation, 60–66 mg/m2 were common doses to be used in second-line chemotherapy for NSCLC. Nevertheless, under such doses, there were no comparative data between classic tri-weekly and Days 1 and 8 weekly schedules. Similar to the results from higher total dose (75 mg/m2) of docetaxel, divided dose (33 mg/m2) was shown as efficacious as tri-weekly schedule in our pilot study but possible different toxicity and QOL. For further confirming this observation, we thus conduct a Phase II randomized trial to compare the toxicity profile, QOL between these two schedules of docetaxel in the treatment of previously treated NSCLC patients. The secondary endpoints of evaluation are the response rate, TTP and median survival rate.
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SUBJECTS AND METHODS |
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PATIENT ELIGIBILITY
To be eligible for study, all patients must have inclusion criteria of histologically or cytologically confirmed Stage IIIb or IV NSCLC; age of 18–80 years; clinical evaluable or dimensionally measurable disease, of which are stable, or refractory to previous chemotherapy; for the patient who previously received radiotherapy, target lesion of chemotherapy should not be included in previous radiation area; Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less with adequate bone marrow reserve characterized by white blood cell counts (3000/mm3, platelets (100 000/mm3 and hemoglobin (10 g/dl; patients previously treated by surgery need to demonstrate progressive disease (PD). Exclusion criteria were as follows: active metastases of central nervous system; inadequate hepatic function (serum bilirubin, AST or ALT level >1.5 times above normal ranges; alkaline phosphatase >2.5 times normal) or renal function (creatinine clearance <50 ml/min.); pregnancy, not using appropriate birth control during the study, or breast feeding; serious concomitant systemic disorders incompatible with the study (e.g. poorly controlled diabetes mellitus); second primary malignancy except in situ carcinoma of the uterine cervix or adequately treated basal cell carcinoma of the skin; active cardiac disease requiring therapy (exception: controlled cardiac failure); neurological conditions that could interfere with evaluation of neurology; and any psychological condition that precluded adequate treatment and/or a follow-up.
The study protocol was approved by the review board of the hospital and all patients provided written informed consent before enrollment.
TREATMENT SCHEME
After enrollment, all patients underwent a complete medical history and physical examination, including a full neurological examination and documentation of ECOG performance status. The patients were randomized to arm A or arm B without further stratification. In arm A, the docetaxel 66 mg/m2 on Day 1; and arm B, the docetaxel 33 mg/m2 on Days 1 and 8, were given intravenously as a 1 h infusion every 3 weeks. Patients were premedicated with oral dexamethasone of 8 mg bid starting 24 h before each infusion of docetaxel to a total of six doses. Prophylactic antiemetic therapy was routinely prescribed. Chemotherapy was continued until disease progression, development of unacceptable toxicity or no more than nine cycles.
ASSESSMENT OF TOXICITY, DOSE ESCALATION, QOL AND RESPONSE
Toxicity was evaluated according to National Cancer Institute Common Toxicity Criteria Version 2.0. Dose might be escalated (10% per cycle) if no discomfort and titrated 50% off when Grade 2 toxicity occurred.
Lung Cancer Symptom Scale (LCSS) (18,19), a validated patient-rated questionnaire to appreciate the full benefits of treatment for lung cancer was used for the assessments of QOL. The QOL evaluations were carried out at the beginning of chemotherapy and completion of the second-line chemotherapy. The LCSS includes six important symptoms (appetite, fatigue, cough, dyspnea, hemoptysis and pain), determined by patients and health-care professionals, and three global items (symptoms from illness, daily activity and overall QOL). All items were measured by visual–analog scales using 100 mm lines to assess the intensity of responses.
Patients underwent baseline tumor assessment and then were assessed for response every two cycles of chemotherapy until documentation of disease progression or completion of chemotherapy. Complete response (CR), partial response (PR), stable disease (SD) and PD were reported according to World Health Organization and International Union Against Cancer Criteria (20). ORR was the sum of CR and PR whereas disease control rate (DCR) was the sum of CR, PR and SD. TTP was defined as the interval from the date of randomization to the date of documented disease progression and overall survival rates were measured according to the interval from the date of randomization to the date of death or last follow-up information for living patients.
STATISTICS
A sample size of 50 evaluable patients was estimated to provide a 5% two-sided alpha significance level to observe a decrease in the hematological toxicity from 70 to 35% with a power of 0.8. This is based on the reported toxicity rates of 85% with dose of 75 mg/m2 and 63% with 60 mg/m2 (15,17). The expected hematologic toxicity of the test arm was 35% because the dosage per administration of this arm is half of the control arm.
The primary analysis of toxicity profiles used Pearson Chi-square test. The changes in LCSS were compared by Mann–Whitney test. Dose intensity and ORRs of the two regimens were compared by Fisher's exact test. To correlate the responses of docetaxel to that of front-line chemotherapy, Pearson Chi-square was used. The survival curves were analysed via Kaplan–Meier method and log-rank test.
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RESULTS |
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PATIENT'S CHARACTERISTICS
The baseline patient demographics are summarized in Table 1. The major prognostic factors such as staging, performance status or age were quite equally distributed in both arms. Fifty patients were randomized and all data were available for analysis. The front-line regimens used in arm A included vinorelbine and cisplatin in 7 cases, gemcitabine and cisplatin in 16 cases, gemcitabine, ifosfamide, and cisplatin in 1 case, and etoposide and cisplatin in 1 case. In arm B, the front-line regimens included vinorelbine and cisplatin in 3 cases, gemcitabine and cisplatin in 18 cases, gemcitabine, ifosfamide, and cisplatin in 3 cases, and gemcitabine and paclitaxel in 1 case. The front-line responses in arm A were ORR 44%, SD 20% and PD 32%, and in arm B were ORR 28%, SD 36% and PD 28% (Table 1).
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TOXICITY AND QOL
The toxicity was evaluated in all treated patients and in all cycles. Arm A had significantly higher Grades 3 and 4 leukopenia (P = 0.003) and neutropenia (P = 0.005) (Table 2). No significant interstitial pneumonitis was noted in both groups.
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There were 21 out of 25 patients (84%) in arm A and 22 out of 25 patients (88%) in arm B completing the questionnaires. In arm A, the changes in LCSS were as follows: appetite (median of 0, –90 to 48), fatigue (median of 6, –36 to 57), cough (median of 3, –71 to 53), dyspnea (median of –1, –48 to 37), hemoptysis (median of 0, –72 to 14), chest pain (median of 0, –83 to 83), symptoms from illness (median of 8, –57 to 46), daily activities (median of 0, –61 to 50), and overall QOL (median 0, –72 to 54). In arm B, the changes in LCSS were as follows: appetite (median of –14.5, –79 to 52), fatigue (median of –15, –67 to 34), cough (median of 4, –77 to 57), dyspnea (median of –10, –74 to 32), hemoptysis (median of 0, –75 to 8), chest pain (median of 0, –100 to 43), symptoms from illness (median of 0, –46 to 30), daily activities (median of –12, –64 to 21), and overall QOL (median –7, –75 to 20). In contrast to the lower toxicity profiles in arm B, both arms have similar changes in LCSS and patients in arm A have even less compromised QOL in terms of appetite (Figs 1 and 2). In consideration of imbalance between male/female ratio in both groups, we also compared the LCSS between male and female patients either in arm A, arm B, or in total group. There is no significant difference between male and female.
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TREATMENT AND RESPONSE
The dose intensities and treatment efficacy were demonstrated in Table 3. Both groups have the same 1 year survival rate (36%) and 2 year survival rate (12%) (Fig. 3).
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The responsiveness in second-line docetaxel was also significantly correlated to previously front-line treatment (Table 4). For those who were refractory to front-line chemotherapy none was responsive to docetaxel, and 80% of them showed progression after second-line docetaxel (P = 0.032).
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After second-line treatment, slightly more patients continued further therapy (13 patients) in arm A than 11 patients in arm B. The willing for subsequent treatment was not significantly different.
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DISCUSSION |
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This is a report of randomized control study to compare the efficacy, toxicity and QOL of classic tri-weekly and Days 1 and 8 weekly schedules of docetaxel in a lower dose (60–66 mg/m2) in oriental patients with previous treated NSCLC.
As early as its introduction in 1990s, docetaxel 100 mg/m2 has been demonstrated activity in second-line chemotherapy with an acceptable toxicity profile in NSCLC (9,21). In the study by Shepherd et al. (8), the benefits of docetaxel compared with corresponding best supportive care patients were more significant under the dose of 75 mg/m2 than 100 mg/m2 with a lower rate of neutropenic fever. Since palliation is the most important goal of second-line therapy, it is reasonable to choose a dose with lower toxicity while conserving its anticancer activity.
Observed differences in clinical toxicity to docetaxel between Asian and Western patients have been clearly documented (14). This may be related to pharmacokinetic differences that was contributed by ethnic diversity of polymorphisms in CYP3A isoenzymes, which metabolize docetaxel to less active metabolites (22,23). In Asian, lower CYP3A activity was found (24). Thus, these findings also explain the similar anticancer activity under lower dose of docetaxel in Asian. To examine our results, either tri-weekly or Days 1 and 8 weekly schedules, the DCR, TTP and survival rates are no more inferior to the data of classical doses (9).
To improve the toxicity, divided schedules have also been provided in other studies. The most popular regimen in Western countries was weekly administration of 33–36 mg/m2 docetaxel for 6 weeks and 2 weeks of rest (25,26). To be compared with the classical tri-weekly schedule under dose of 75 mg/m2, this schedule has been shown equal efficacy and survival rate. In the study by Camps et al. (25) from Spain, despite similar Grades 3–4 toxicities in both schedules, the docetaxel 36 mg/m2 weekly arm has even more Grades 1–2 toxicities significantly. However, the reported Grades 3–4 toxicities are much lower than other studies. Another report by Gridelli et al. (26) from Italy has been shown less toxicity, equal global QOL and some advantages on pain, cough and hair loss for the weekly schedule. In contrast to their results, our finding did not favor the divided schedule. To explain the difference, total dose may be an important factor. With 33.3 mg/m2 weekly schedule, the total dose was much less than that with 75 mg/m2 tri-weekly, thus could lead to a better QOL.
In comparison of the two schedules in our study, the tri-weekly group has a significantly higher Grade 3 or 4 leukopenia (60 versus 20%, P = 0.003) and neutropenia (68 versus 28%, P = 0.005), whereas both have similar efficacy (DCR, TTP, median survival, 1 year and 2 year survival). Interestingly, despite more hematological toxicity in tri-weekly group, the Days 1 and 8 weekly group exhibited a trend of more compromised QOL, especially on appetite (P = 0.03). Besides, despite higher toxicity in tri-weekly group, the mean total dose and the completed cycle numbers were similar. These may reflect the difference between objective and subjective evaluation in cancer treatment. Suppose that duration of symptoms may be a major concern rather than severity subjectively, the patient may feel more troublesome in weekly schedule, leading to a worse QOL. As a consideration of palliation, we conclude that the Days 1 and 8 weekly schedules are no better than the tri-weekly one but could be an alternative choice.
In contrast to the result by Gandara et al. (27) that second-line docetaxel exhibits its efficacy both in platinum sensitive and refractory NSCLC, our results showed significantly more favorable outcome to the group that was response to front-line chemotherapy (28% PD in previous response cases, 43% PD in previous stable cases and 80% PD in previous refractory cases, P = 0.032). Nevertheless, even for the patients refractory to front-line chemotherapy, the response to docetaxel is still acceptable (DCR = 20%). From this point of view, on comparing the efficacy of newer second-line treatment to docetaxel, it is prudent to stratify the patient population according to relapse or refractory status.
With the advent of newer agents such as erlotinib and pemetrexed (28,29), which have been shown clinically equivalent efficacy and possibly fewer side effects in comparison with docetaxel in the second-line treatment of patients with advanced NSCLC, the monopoly role of docetaxel may be challenged. However, since erlotinib has a preferable response in adenocarcinoma and the dose of docetaxel used in comparing pemetrexed and docetaxel was higher than that in our study, the authors think that more clinical evidence may be necessary to settle down this issue.
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CONCLUSION |
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TOPAbstractINTRODUCTIONSUBJECTS AND METHODSRESULTSDISCUSSIONCONCLUSIONReferences |
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While Days 1 and 8 weekly docetaxel schedules show higher ORR and less hematological toxicity, there is no advantage to tri-week schedule in terms of TTP and survival, but more compromised QOL. From this point of view, the Days 1 and 8 weekly schedules are no better than the tri-weekly one, but could be an alternative choice when toxicity is a concern.
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References |
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