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SYMPOSIUM FOR METRONOMICS AND ECONOMICS- ORIGINAL ARTICLE
Year : 2013  |  Volume : 50  |  Issue : 2  |  Page : 128-134
 

Metronomic weekly paclitaxel in advanced unresectable esophageal cancer


1 Department of Medical Oncology, Tata Memorial Hospital, Parel, Mumbai, Maharashtra, India
2 Department of Nuclear Medicine, Tata Memorial Hospital, Parel, Mumbai, Maharashtra, India

Date of Web Publication27-Aug-2013

Correspondence Address:
K Prabhash
Department of Medical Oncology, Tata Memorial Hospital, Parel, Mumbai, Maharashtra
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0019-509X.117020

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 » Abstract 

Context: Advanced esophageal cancer is aggressive with an expected median survival of 6-7 months. Combination chemotherapy regimens provide effective palliation, but result in substantial toxicity. Materials and Methods: Retrospective analysis of prospectively collected data of patients with advanced esophageal cancer, not amenable to definitive intent therapy who were treated with intravenous weekly paclitaxel. Results: Between October 2010 and August 2011, 51 patients were included. Median age was 56 years, with a male: female ratio of 2.9:1. 29% were mid esophageal and 55% were lower third and gastroesophageal junction tumors. 65% of the tumors had squamous histology. Performance status was > 2 in 45%. 61% patients had received prior therapy, either definitive or palliative. 51% patients were platinum-pre-treated and 29% had received prior 3 weekly paclitaxel. 76% patients had distant metastases. Median number of cycles of weekly paclitaxel delivered was 11. 71% of patients had improvement in dysphagia, with a median time to symptom improvement of 9 days. In 72% patients, the feeding nasogastric tube could be removed. Overall response rate was 49% (complete remission: 4%, partial remission: 45%, stable disease: 13%). Median progression free survival was 4.7 months (confidence interval [95% CI: 3.7-5.7 months]) and median overall survival was 7.5 months (95% CI: 3.1-11.8 months). Histopathology, performance status and pre-treatment albumin significantly affected survival. The most common grade 3/4 toxicities included hyponatremia (14%), fatigue (16%), diarrhea (12%), anemia (31%), neutropenia (10%) and febrile neutropenia (4%). Conclusions: Metronomic weekly paclitaxel chemotherapy may provide palliative benefit in advanced unresectable metastatic esophageal cancer with minimal toxicity.


Keywords: Chemotherapy, esophageal neoplasms, esophagogastric junction, esophagus, metronomic, paclitaxel, palliative


How to cite this article:
Noronha V, Patil V, Bhosale B, Joshi A, Purandare N, Prabhash K. Metronomic weekly paclitaxel in advanced unresectable esophageal cancer. Indian J Cancer 2013;50:128-34

How to cite this URL:
Noronha V, Patil V, Bhosale B, Joshi A, Purandare N, Prabhash K. Metronomic weekly paclitaxel in advanced unresectable esophageal cancer. Indian J Cancer [serial online] 2013 [cited 2021 May 7];50:128-34. Available from: https://www.indianjcancer.com/text.asp?2013/50/2/128/117020



 » Introduction Top


Esophageal cancer is a highly aggressive malignancy. In spite of all modern antineoplastic therapies, including surgery, radiation and chemotherapy, the case fatality rate remains 90%. [1] In 2010, there were 16,640 new cases of esophageal cancer diagnosed in the United States, with an estimated 14,500 deaths in the same year. In the 15 years from 1990 to 2006, the death rate has been decreasing for several cancers, for example the death rates of lung cancer and prostate cancer have decreased by 26% and 39% respectively. However, the death rate from esophagus cancer has increased by almost 10%. [2]

The median survival after esophagectomy is only 15-18 months. The 5 year overall survival (OS) rate for all stages is between 20% and 25%. [1] Data from the Bombay Cancer Registry for the time period between 1992 and 1999 revealed that the 5 year age-standardized relative survival rate for esophageal cancer in Mumbai, India was 14%. [3] In patients with advanced unresectable or metastatic disease, the prognosis is grim with an estimated median survival of 6-7 months, regardless of whether the patient is treated with single agent chemotherapy or aggressive 3-drug combination chemotherapy. [4],[5],[6],[7] The toxicity of combination chemotherapy is substantial; hence, the utility of using aggressive combination chemotherapy in this palliative setting has been questioned. [8]

Taxanes have demonstrated promising activity in patients with esophageal cancer. [4],[5] Both docetaxel and paclitaxel are effective in platinum-refractory esophageal cancer, with the toxicity profile favoring paclitaxel. [9] Paclitaxel is an old and well-understood chemotherapeutic agent. Its antineoplastic activity was first discovered in 1963, when the bark of the Western yew tree, Taxus brevifolia, was found to have antineoplastic activity in a cell line. [10] The mechanism of action was later elucidated to be through tubulin-binding, causing stabilization of the microtubule assembly, ultimately leading to mitotic arrest and apoptosis. [11]

Paclitaxel has been used in various schedules, ranging from 24 h infusions to short 1 h infusions. A Cochrane review examining various schedules of paclitaxel infusion in patients with advanced adenocarcinoma concluded that shorter infusions were as efficacious and less toxic. [12] Traditionally, paclitaxel is administered at a dose of 175-225 mg/m 2 over 3 h every 3 weeks. Metronomic scheduling, i.e., lower doses at more frequent intervals, has been attempted and is more effective in some malignancies, for example, breast cancer. [13] This metronomic scheduling has also been shown to be efficacious in patients with advanced esophageal cancer, with very manageable toxicity. [14],[15] We present our experience with metronomic weekly paclitaxel in patients with advanced unresectable, metastatic or recurrent esophageal and esophagogastric cancer.


 » Materials and Methods Top


This is a retrospective analysis of a prospectively collected database from Tata Memorial Hospital in Mumbai, India. Patients with advanced cancer of the esophagus or gastroesophageal junction, both adenocarcinoma and squamous cell carcinoma, who were treated with palliative intent, were included. The only exclusion criteria was > grade 2 peripheral neuropathy. All patients were evaluated at baseline, including history and physical examination, laboratory parameters, upper endoscopy (if indicated) and imaging studies. Patients were treated with paclitaxel at 80 mg/m 2 as a 1 h infusion given weekly with standard pre-medications, including antihistamines, antiemetics, H2 antagonists and steroids. Each dose of chemotherapy was considered as one cycle. If there was no evidence of hypersensitivity in the first few cycles of chemotherapy, steroids were omitted in subsequent cycles. Patients who had received at least four cycles of chemotherapy were included in the analysis for both toxicity and response assessment. Complete blood count was checked weekly and patients were evaluated by a physician weekly prior to chemotherapy. Serum biochemistry (including fasting blood glucose, liver functions and renal functions) and serum electrolytes were checked once a month. Toxicity was graded according to common terminology criteria for adverse events v4.03.

Imaging studies were repeated approximately every eight cycles. Response was calculated using standard response evaluation criteria in solid tumors definitions, with the measurements including the maximum esophageal thickness added to other measurable lesions. Progression free survival (PFS) was calculated from the date of receiving first dose of paclitaxel chemotherapy to the date of radiologic progression, symptomatic deterioration in the absence of progressive disease on scan, start of next line of therapy due to any reason (logistic reasons, financial constraints or unacceptable toxicity) or death from any cause. OS was calculated from the date of first chemotherapy to the date of death from any cause. Statistical Package for the Social Sciences version 16 was used for statistical analysis.


 » Results Top


Between October 2010 and August 2011, there were 51 patients who were included in the analysis. The cut-off date for last follow-up was December 2011. Patient details are included in [Table 1]. Details of therapies administered prior to starting weekly paclitaxel are given in [Table 2]. 68% patients had both loco-regional and distant metastatic disease at the time of starting weekly paclitaxel. The common sites of metastases were lung (24%), liver (20%) and retroperitoneal lymph nodes (12%).
Table 1: Baseline patient characteristics


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Table 2: Details of prior therapy and relapses before starting metronomic paclitaxel therapy


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Details of weekly paclitaxel administration are given in [Table 3]. The median number of cycles delivered was 11. Regarding symptom control, 71% patients had improvement in dysphagia while on weekly paclitaxel chemotherapy [Figure 1] and [Figure 2]. No patients had worsening in dysphagia during the chemotherapy, including patients who had progressive disease as best response. The median time to symptom relief was 9 days (range: 3-82 days). 15 patients had grade 3 dysphagia at the start of chemotherapy: In eight patients, dysphagia completely resolved while dysphagia improved to grade 1 in 3 patients and grade 2 in 4 patients. Eleven patients required a feeding nasogastric tube prior to starting chemotherapy: In eight patients, the tube was removed during the course of chemotherapy as a result of significant improvement in dysphagia. Radiologic response to weekly paclitaxel included (complete remission [CR: 4%], partial remission [PR: 45%], stable disease [SD: 29%] and Progressive disease [PD: 16%]). Patients who had received platinum based chemotherapy prior to weekly paclitaxel (n = 26) had a response rate of 35% while patients who were platinum-naïve (n = 25) had a response rate of 64% (P = 0.04).
Figure 1: Dysphagia at the start of weekly paclitaxel metronomic chemotherapy

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Figure 2: Dysphagia at the end of weekly paclitaxel metronomic chemotherapy

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Table 3: Details of paclitaxel administration


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The toxicity of weekly paclitaxel is detailed in [Table 4]. Grade 3 or 4 neutropenia and anemia occurred in 10% and 31% of the patients respectively. 4% of patients developed febrile neutropenia. The common non-hematologic grade 3/4 toxicities included fatigue in 16%, hyponatremia in 14%, diarrhea in 12% and respiratory infection (most commonly aspiration pneumonia) in 8% of the patients.
Table 4: Toxicity of weekly paclitaxel


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Thirty nine patients discontinued therapy. The reasons for discontinuation included progressive disease in 25, logistics-6, toxicity-2 (peripheral neuropathy and toxic erythroderma) and in six patients, the response to palliative intent weekly paclitaxel chemotherapy was good enough to render the disease amenable to definitive intent therapy (surgery in one patient and chemoradiotherapy in five patients). The median PFS was 4.7 months (95% confidence intervals: 3.7-5.7 months) and the median estimated OS was 7.5 months (95% CI: 3.1-11.8 months) [Figure 3] and [Figure 4]. The median follow-up for the surviving patients was 7.5 months. Using univariate log rank analysis, histopathology had a significant impact on PFS, while performance status and pre-treatment albumin affected OS. Patients with adenocarcinoma fared poorly with an estimated median PFS of 3.6 months while in patients with squamous histology, the estimated median PFS was 5.9 months. In patients with an eastern co-operative oncology group (ECOG) performance status of 0 or 1, the estimated median OS was 10.6 months while the patients with PS > 1 had an estimated median OS of 5.4 months.
Figure 3: Progression free survival of patients on weekly paclitaxel chemotherapy

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Figure 4: Overall survival of patients on weekly paclitaxel chemotherapy

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 » Discussion Top


Two other studies have described the use of weekly paclitaxel in advanced esophageal cancer. In the first study, Ilson et al. used paclitaxel at 80 mg/m 2 in 102 patients with advanced esophageal cancer. They reported a response rate of 13% (all partial responses), a median duration of response of 172 days (5.7 months) and a median OS of 274 days (9.1 months). All patients had an ECOG performance status of < 2, none had received prior chemotherapy in the metastatic setting, the majority of patients had adenocarcinoma histology (66%) and were chemotherapy naïve (76%). [14] In a subsequent study by Kato et al., there were 53 patients with recurrent or advanced esophageal cancer, all of whom had received prior platinum based chemotherapy. 98% of the patients had squamous cell carcinoma and all patients had ECOG performance status of <1. Patients were treated with weekly paclitaxel at 100 mg/m 2 for 6 weeks on, 1 week off, every 8 weeks. The response rate was 44.2%, the median duration of response was 4.8 months and the median OS was 10.4 months. [15] In both the above studies, prior therapy with Paclitaxel was not permitted. Our results are comparable to the study by Kato et al., which also included platinum pre-treated patients. Our PFS is identical and the OS in good PS patients (which were the type of patients included in the Kato study) is also identical. The results by Ilson et al. are slightly better; however, this was essentially a chemotherapy-naïve, good performance status population and from our study we have found that these factors impact on the response and survival outcome of chemotherapy.

Our patient population was different from the two previous studies in several ways: We included 45% of patients who had a performance status of >2, over 50% of the patients had received prior chemotherapy: 51% had received prior platinum and 29% of the patients had received prior paclitaxel (3 weekly). Thus, our patient group represents a real-world unselected group, making the results applicable to any patient population.

There are several large trials examining the use of combination chemotherapy in advanced esophagogastric cancer. Combination chemotherapy has been used with modest benefit with median improvement in survival being 1-3 months. There has been substantial toxicity with these regimens. Grade 3-4 toxicity was present in 69% patients receiving docetaxel, 5-fluorouracil (5-FU), cisplatin protocol, 36% patients receiving epirubicin, 5-FU, cisplatin developed grade 3-4 neutropenia and there were 6% deaths within 60 days in the REAL-2 trial (epirubicin plus cisplatin or oxaliplatin plus 5-FU or capecitabine). [6],[7],[16],[17],[18] In our setting, weekly paclitaxel was effective in patients with advanced or metastatic esophageal or GE junction cancer, with an overall response rate of 49% (CR: 4%, PR: 45%) and disease stabilization rate of 13%. The median PFS was 4.7 months and the median OS was 7.5 months. The toxicity of weekly paclitaxel was easily manageable. The most common grade 3/4 toxicities included hyponatremia, fatigue and diarrhea. Grade 3/4 neutropenia occurred in 10% of the patients while 4% patients had febrile neutropenia. There were no toxic deaths. Comparison of the results from our study cannot be made to the above mentioned large randomized trials; however, with even aggressive combination chemotherapy regimens, maximum response rate achievable is 48%, the longest median PFS achieved is 7.4 months and the maximum median OS is 11.2 months and these results are achieved at the cost of significant toxicity. Thus, there is a potential to compare metronomic weekly paclitaxel chemotherapy to multidrug combination chemotherapy to evaluate if we can achieve similar clinical benefits at lower toxicity, thus overall, at improved quality-of-life.

The role of palliative chemotherapy in advanced esophageal cancer is unclear. No trial has shown that chemotherapy prolongs survival in metastatic esophageal cancer. [5],[19] Thus, currently the major role of chemotherapy in this setting is for symptom palliation. We found that over 70% of patients had improvement in dysphagia after starting chemotherapy, with a median time to symptom improvement of 9 days. In 72% patients, the feeding nasogastric tube could be removed after starting chemotherapy, due to significant dysphagia relief. Even patients without objective evidence of tumor response on restaging scans had improvement in dysphagia. Other options for dysphagia relief include self-expanding metal stents (SEMS), radiotherapy-either external beam (EBRT) or intraluminal brachytherapy (ILRT), dilatation, laser or chemoradiotherapy. A Cochrane meta-analysis revealed that SEMS insertion, brachytherapy and laser ablation are equally effective for palliation of dysphagia. [20] Amdal et al. reported that there was no difference in dysphagia relief between EBRT ± ILRT, ILRT alone, endoluminal stent, laser, chemotherapy and best supportive care. [21] 63% of our patients had dysphagia at presentation. In addition, there were a multitude of baseline symptoms including other loco-regional symptoms like cough, often with hemoptysis (30%), hoarseness (24%), chest pain (20%), vomiting and regurgitation (24%), back pain (27%) and painful lymph nodal swelling (4%). Systemic symptoms included anorexia (20%), weight loss (27%), weakness (24%), abdominal pain (24%), abdominal distention (4%), shortness of breath (14%) and other uncommon symptoms in less than 10% patients including jaundice, leg swelling, fever, mouth sores, dizziness, body ache, bone pains, insomnia, constipation, headache and seizures. Local therapies like SEMS provide effective palliation of dysphagia, but do not improve some local symptoms like hoarseness, chest pain and do not improve any systemic symptoms. In our patients, chemotherapy provided palliation of most symptoms, including dysphagia, which was relatively prolonged. Thus, effective palliation in advanced esophageal cancer is complex and includes many systemic symptoms, which can be decreased only by systemic therapy.


 » Conclusion Top


Esophageal cancer is an aggressive malignancy with limited survival in the advanced and metastatic setting. Metronomic chemotherapy may provide palliative benefit and can be considered. There is a need for a well conducted randomized controlled trial to establish the role of chemotherapy in metastatic esophageal cancer.


 » Acknowledgments Top


  1. Ms. Dipti Nakti (Trial coordinator, Tata Memorial Hospital, Mumbai), for superb data entry.
  2. Dr. Shripad Banavali (Head of the Department, Medical Oncology, Tata Memorial Hospital, Mumbai), for constant support.
  3. Members of the thoracic disease management group at Tata Memorial Hospital, Mumbai


 
 » References Top

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    Figures

  [Figure 1], [Figure 2], [Figure 3], [Figure 4]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4]

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