[Show abstract][Hide abstract] ABSTRACT: The aim of this study was to compare survival of resected and unresected patients in a large cohort of patients with metastases to the pancreas from renal cell carcinoma (PM-RCC).
Data from 16 Italian centers involved in the treatment of metastatic RCC were retrospectively collected. The Kaplan-Meier and log-rank test methods were used to evaluate overall survival (OS). Clinical variables considered were sex, age, concomitant metastasis to other sites, surgical resection of PM-RCC, and time to PM-RCC occurrence.
Overall, 103 consecutive patients with radically resected primary tumors were enrolled in the analysis. PM-RCCs were synchronous in only three patients (3 %). In 56 patients (54 %), the pancreas was the only metastatic site, whereas in the other 47 patients, lung (57 %), lymph nodes (28 %), and liver (21 %) were the most common concomitant metastatic sites. Median time for PM-RCC occurrence was 9.6 years (range 0-24 years) after nephrectomy. Surgical resection of PM-RCC was performed in 44 patients (median OS 103 months), while 59 patients were treated with tyrosine kinase inhibitors (TKIs; median OS 86 months) (p = 0.201). At multivariate analysis, Memorial Sloan Kettering Cancer Center risk group was the only independent prognostic factor. None of the other clinical variables, such as age, sex, pancreatic surgery, or the presence of concomitant metastases, were significantly associated with outcome in PM-RCC patients.
The presence of PM-RCC is associated with a long survival, and surgical resection does not improve survival in comparison with TKI therapy. However, surgical resection leads to a percentage of disease-free PM-RCC patients.
Annals of Surgical Oncology 12/2014; · 4.12 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: von Hippel-Lindau (VHL) is a rare hereditary condition caused by germline alteration of VHL gene predisposing to renal carcinoma and multiple other tumors. Since acquired dysregulation of VHL-dependent pathways is often present in patients with sporadic RCC treated with the anti-angiogenic drug sunitinib, there is a strong rationale to use the same drug in VHL patients with progressive disease in the kidneys or other sites. Our primary objective was to evaluate the activity of sunitinib in terms of progression-free survival. Secondary objectives: rate of radiological response, patterns of responses in different organs, treatment-related toxicities. We performed a retrospective analysis of sunitinib therapy in genetically-confirmed VHL patients treated at our Institution for multifocal or advanced RCC. From February 2007 to July 2012, 14 VHL patients started first-line sunitinib for recurrent or progressing RCC, mean age 48 years (27-71). Nine patients achieved a partial RECIST response (64.3 %); responses were noted not only in renal and hepatic lesions but also in pancreatic nodules. Most lesions showed density reduction, while all CNS haemangioblastoma lesions remained stable. At a median follow-up of 37 months, six patients have progressed and three patients died, with a progression-free rate at 2 years of 71.4 %. Sunitinib may therefore achieve a fairly good disease control in VHL patients. Radiological responses may be obtained not only in renal tumors but also in synchronous VHL-related lesions, especially pancreatic solid nodules whose exact nature (metastatic RCC or neuroendocrine tumor) cannot be ruled out without invasive biopsy.
[Show abstract][Hide abstract] ABSTRACT: This review focuses on epidemiology, aetiology, clinical presentation, diagnosis, management, prognosis and follow-up of soft tissue sarcomas (STS) involving limbs and trunk. Any patient with a suspected STS should be referred to a specialized sarcoma centre and managed by a multidisciplinary group. The standard treatment is surgical excision followed by adjuvant radiotherapy (RT). Radiotherapy is recommended in patients with intermediate-or high-grade tumors, >5 cm of diameter or <5 cm. RT may be indicated in low grade, deep and large-size STS and/or in absence of adequate margins, after discussion within a multidisciplinary group. Neoadjuvant radiotherapy and chemotherapy should be taken into consideration for patients with borderline resectable tumors. In selected cases, amputation may be the only curative option. Isolated limb perfusion is a pre-operative treatment that may allow for amputation to be avoided. Adjuvant chemotherapy should be considered only in selected cases. Regular follow-up with clinical examination, ultrasound (US) or magnetic resonance imaging (MRI) to exclude local recurrences and chest-X-ray or chest computed tomography (CT) to exclude metastatic disease is recommended. For metastatic disease, doxorubicin is the first-line standard therapy. Second-line agents include trabectedin, ifosfamide, dacarbazine and the combination of gemcitabine-plus-docetaxel. Surgical resection of local recurrences or lung metastases should be evaluated in selected cases. Soft tissue sarcomas (STS) are a rare and heterogeneous group of tumors, ubiquitous in their site of origin. A multi-disciplinary approach (involving pathologists, radiologists, surgeons, radiation therapists, medical oncologists) is necessary in all cases. Over the past years, many advances have been made in the diagnosis and treatment of these malignancies (1-5). In UK, clinical management guidelines have been developed under the auspices of The British Sarcoma Group (BSG) and the National Institute for Health and Care Excellence (NICE) has drawn up the "Improving Outcomes Guidance for people with sarcoma (IOG)" (3, 4). In USA, The National Comprhensive Cancer Network (NCCN) has recently published the soft tissue sarcoma guidelines (1). In Europe, the European Society of Medical Oncology (ESMO) and, in Italy, the Italian Society of Medical Oncology (AIOM) have just revised their guidelines (2, 5). According to the NCCN's Categories of Evidence and Consensus for STS, reported in Table I, all recommendations are category 2A unless otherwise specified in the text (1). Moreover, this review is based on the BSG, NCCS and ESMO guidelines together with the National Institute for Health (NIH) and Clinical Excellence Improving Guidance for people with sarcoma (NICE-IOG) and all the most recent scientific literature related to STS is based on searches conducted in: Medline, CANCERNET PDQ, Cochrane Library Database of Systematic Reviews.
Anticancer research 10/2014; 34:5251-5262. · 1.71 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Purpose:A subset of patients with KIT/PDGFRA wild-type gastrointestinal stromal tumors show loss of function of succinate dehydrogenase, mostly due to germ-line mutations of succinate dehydrogenase subunits, with a predominance of succinate dehydrogenase subunit A. The clinical outcome of these patients seems favorable, as reported in small series in which patients were individually described. This work evaluates a retrospective survival analysis of a series of patients with metastatic KIT/PDGFRA wild-type succinate dehydrogenase-deficient gastrointestinal stromal tumors.Methods:Sixty-nine patients with metastatic gastrointestinal stromal tumors were included in the study (11 KIT/PDGFRA wild-type, of whom 6 were succinate dehydrogenase deficient, 5 were non-succinate dehydrogenase deficient, and 58 were KIT/PDGFRA mutant). All six succinate dehydrogenase-deficient patients harbored SDHA mutations. Kaplan-Meier curves and log-rank tests were used to compare the survival of patients with succinate dehydrogenase subunit A-mutant gastrointestinal stromal tumors with that of KIT/PDGFRA wild-type patients without succinate dehydrogenase deficiency and patients with KIT/PDGFRA-mutant gastrointestinal stromal tumors.Results:Follow-up ranged from 8.5 to 200.7 months. The difference between succinate dehydrogenase subunit A-mutant gastrointestinal stromal tumors and KIT/PDGFRA-mutant or KIT/PDGFRA wild-type non-succinate dehydrogenase deficient gastrointestinal stromal tumors was significant considering different analyses (P = 0.007 and P = 0.033, respectively, from diagnosis of gastrointestinal stromal tumor for the whole study population; P = 0.005 and P = 0.018, respectively, from diagnosis of metastatic disease for the whole study population; P = 0.007 for only patients who were metastatic at diagnosis).Conclusion:Patients with metastatic KIT/PDGFRA wild-type succinate dehydrogenase-deficient gastrointestinal stromal tumors harboring succinate dehydrogenase subunit A mutations present an impressively long survival. These patients should be identified in clinical practice to better tailor treatments and follow-up over time.Genet Med advance online publication 04 September 2014Genetics in Medicine (2014); doi:10.1038/gim.2014.115.
Genetics in medicine: official journal of the American College of Medical Genetics 09/2014; · 3.92 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Trabectedin is an alkylating agent registered in Europe for the treatment of advanced metastatic soft-tissue sarcomas, whose activity has been documented mainly in liposarcomas or leiomyosarcomas. Here, we report the response achieved in a patient with lung metastases from synovial sarcoma. A man with a large synovial sarcoma of the axilla underwent three cycles of neoadjuvant epirubicin+ifosfamide before complete excision, followed by three additional cycles of chemotherapy and radiotherapy. After 14 months, bilateral lung metastases appeared and were first treated with a prolonged 14-day continuous infusion of high-dose ifosfamide without response, and then with second-line trabectedin. A partial radiological response was achieved; dosage was reduced to 1.1 mg/m because of mild asthenia, grade 3 neutropenia, grade 3 nausea and vomiting, and reversible transaminase elevation. After 9 months of treatment, the lung nodules progressed, the patient received sorafenib, but further progressed and died 19 months after the first appearance of lung metastases. Trabectedin was the only drug that led to a radiological response in this patient with synovial sarcoma, despite being administered at 75% of the standard dose because of dose-limiting nausea and vomiting, in line with more recent data demonstrating activity in translocated sarcomas. We believe that trabectedin represents an attractive option for the treatment of metastatic synovial sarcoma and further clinical studies are warranted.This is an open access article distributed under the Creative Commons Attribution-NonCommercial-NoDerivatives License 4.0, where it is permissible to download, share and reproduce the work in any medium, provided it is properly cited. The work cannot be changed in any way or used commercially. http://creativecommons.org/licenses/by-nc-nd/3.0.
[Show abstract][Hide abstract] ABSTRACT: Late recurrence of renal cell carcinoma (RCC) is not a rare event. The aim of this retrospective study was to investigate the clinico-pathological features and the outcome of patients (pts) treated with sorafenib, sunitinib and pazopanib for late-relapsing renal cell carcinoma (LR-RCC).
The Journal of Urology 07/2014; · 3.75 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Perivascular epithelioid cell tumors (PEComas)are rare soft-tissue tumors with an extremely heterogeneous clinical behavior. They may arise in different organs and may behave indolently or sometimes metastasize with different grades of biological aggressiveness. We report the case of a young woman with a primary inoperable PEComa of the liver with malignant histological features. Since the mTOR pathway is often altered in PEComas and responses have been reported with mTOR-inhibitors such as sirolimus or temsirolimus, we decided to start a neoadjuvant treatment with sirolimus. The patient tolerated the treatment fairly well and after 8 months a favorable tumor shrinkage was obtained. The patient then stopped sirolimus and 2 weeks later underwent partial liver resection, with complete clinical recovery and normal function. The histological report confirmed a malignant PEComa with vascular invasion and negative margins. Then 6additional months of post-operative sirolimus treatment were therefore administered, followed by regular radiological follow-up. For patients with a large and histologically aggressive PEComa, we think that neoadjuvant treatment with mTOR-inhibitor sirolimus may be considered to facilitate surgery and allow early control of a potentially metastatic disease. For selected high-risk patients, the option of adjuvant treatment may be discussed.
World Journal of Surgical Oncology 02/2014; 12(1):46. · 1.09 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Objective
Lymphopenia is associated with toxicity and outcomes in several cancer types. We assessed the association between pre-treatment lymphopenia, toxicity, and clinical outcomes in elderly patients with metastatic renal cell cancer (mRCC) treated with first-line sunitinib. Prognostic factors in these patients were also evaluated.
Patients and methods
We reviewed the clinical records of 181 patients with mRCC aged ≥ 70 years treated with first-line sunitinib in 17 Italian Oncology Units from February 2006 to September 2011. Baseline lymphopenia was defined as lymphocyte counts < 1000/μL.
Twenty-nine (16%) patients had a baseline lymphocyte count < 1000/μL (group A) and 152 (84%) patients had a lymphocyte count ≥ 1000/μL (group B). Although no differences between the two groups were reported in terms of overall response rate (P = 0.207), dose reductions (P = 0.740), discontinuation due to adverse events (P = 0.175) or overall incidence of grade 3–4 toxicities (P = 0.112), more patients in the lymphopenia group had grade 3–4 neutropenia (P = 0.017), grade 3–4 thrombocytopenia (P = 0.017) and grade 3–4 diarrhea (P = 0.006). In multivariate analysis, performance status and Heng score were predictors of progression-free survival (P = 0.015 and P = 0.0006, respectively), while performance status, Heng score, and lymphopenia were found to be significantly associated with overall survival (P = 0.007, P < 0.0001 and P = 0.023, respectively).
Sunitinib appears to be safe and active in elderly patients with lymphopenia. Lymphocyte count is an independent prognostic factor for overall survival in elderly patients with mRCC treated with first-line sunitinib.
Journal of Geriatric Oncology 01/2014; · 1.12 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. ABSTRACT: We investigated whether Circulating Tumor Cells (CTCs) isolated from epithelial tumors could survive and grow in xenotransplants. To this purpose, EpCAM-positive CTCs were enriched by CellSearch platform the only FDA-cleared automated platform that quantifies tumor burden in peripheral blood and provides clinical evidence of predictive and prognostic value. The CTCs were isolated from metastatic prostate (n=6) and breast (n=2) cancer patients. The xenograft assay was developed in 8-week-old NOD/SCID mice that were subcutaneously injected with increasing amounts of CTCs (ranging from 50 to 3000). Human CTCs were found in 8 out of 8 murine peripheral blood (muPB) and in 6 out of 8 murine bone marrow (muBM) samples, after a median follow-up of 10.3 months. Six out of 8 spleens were positive for human cytokeratin. Our assay showed higher successful rate than those previously reported in breast cancer and hepatocellular carcinoma. The role of EpCAM during carcinogenesis is controversial. The identification of human CTCs in muPB, muBM and spleen demonstrates that the EpCAM-positive fraction of CTCs retains the migratory capacity. This is the first experimental evidence that as few as 50 EpCAM-positive prostate cancer CTCs putatively contain metastasis-initiating-cells (MIC). INTRODUCTION The presence of epithelial tumor cells in peripheral blood (PB) of cancer patients has been longtime associated with metastasis development [1, 2]. Recently, an inverse correlation between Circulating Tumor Cells (CTCs) burden and overall survival has been demonstrated in solid tumors [3-5]; moreover, changes in CTC counts have been associated with prognosis as early as the first treatment cycle [6-8]. Despite this clinical evidence, the tumorigenic potential of CTCs still remains to be proven. Several technical and conceptual hitches constrained a definitive demonstration of the CTC role in the metastatic process, such as the lack of an adequate niche to allow CTC growth, and a general consensus about the gold standard method to isolate these rare cells . Concerning the last point, the phenotype(s) of CTCs has not been fully defined yet. To date, it is generally accepted that CTCs are heterogeneous, rare
[Show abstract][Hide abstract] ABSTRACT: Anticancer agents may trigger reactivation of hepatitis B virus infection ensuing in asymptomatic to severe liver damage. Preemptive administration of antiviral agents such as lamivudine to patients receiving cytotoxic chemotherapy has been shown to inhibit viral replication and prevent such events. No data are available so far concerning the coadministration of antiviral agents and everolimus, an oral mammalian target of rapamycin inhibitor recently approved for the treatment of advanced renal cell carcinoma. We present in this study the first case to our knowledge of a hepatitis B surface antigen-positive patient with metastatic renal cell carcinoma who has been successfully treated with prophylactic lamivudine and everolimus. Long-term depletion of viral replication was obtained along with stabilization of lung and bone metastases. Hepatitis B surface antigen positivity may be found in up to 10% of cancer patients but should not be considered a contraindication to treatment with everolimus.
American journal of therapeutics 12/2013; · 1.29 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Mutations of genes encoding the subunits of the succinate dehydrogenase (SDH) complex were described in KIT/PDGFRA wild-type GIST separately in different reports. In this study, we simultaneously sequenced the genome of all subunits, SDHA, SDHB, SDHC, and SDHD in a larger series of KIT/PDGFRA wild-type GIST in order to evaluate the frequency of the mutations and explore their biological role. SDHA, SDHB, SDHC, and SDHD were sequenced on the available samples obtained from 34 KIT/PDGFRA wild-type GISTs. Of these, in 10 cases, both tumor and peripheral blood (PB) were available, in 19 cases only tumor, and in 5 cases only PB. Overall, 9 of the 34 patients with KIT/PDGFRA wild-type GIST carried mutations in one of the four subunits of the SDH complex (six patients in SDHA, two in SDHB, one in SDHC). WB and immunohistochemistry analysis showed that patients with KIT/PDGFRA wild-type GIST who harbored SDHA mutations exhibited a significant downregulation of both SDHA and SDHB protein expression, with respect to the other GIST lacking SDH mutations and to KIT/PDGFRA-mutated GIST. Clinically, four out of six patients with SDHA mutations presented with metastatic disease at diagnosis with a very slow, indolent course. Patients with KIT/PDGFRA wild-type GIST may harbor germline and/or de novo mutations of SDH complex with prevalence for mutations within SDHA, which is associated with a downregulation of SDHA and SDHB protein expression. The presence of germline mutations may suggest that these patients should be followed up for the risk of development of other cancers.European Journal of Human Genetics advance online publication, 24 April 2013; doi:10.1038/ejhg.2013.80.
European journal of human genetics: EJHG 04/2013; · 3.56 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Background
The impact of adherence to clinical practice guidelines (CPGs) for loco-regional treatment (i.e. surgery and radiotherapy) and chemotherapy on local disease control and survival in sarcoma patients was investigated in a European study conducted in an Italian region (Veneto).Patients and methodsThe completeness of the adherence to the Italian CPGs for sarcomas treatment was assessed by comparing the patient's charts and the CPGs. Propensity score-adjusted multivariate survival analysis was used to assess the impact of CPGs adherence on patient clinical outcomes.ResultsA total of 151 patients were included. Adherence to CPGs for loco-regional therapy and chemotherapy was observed in 106 out of 147 (70.2%) and 129 out of 139 (85.4%) patients, respectively. Non-adherence to CPGs for loco-regional treatment was independently associated with AJCC stage III disease [odds ratio (OR) 1.77, P = 0.011] and tumor-positive excision margin (OR 3.55, P = 0.003). Patients not treated according to the CPGs were at a higher risk of local recurrence [hazard ratio (HR) 5.4, P < 0.001] and had a shorter sarcoma-specific survival (HR 4.05, P < 0.001), independently of tumor stage.Conclusions
Incomplete adherence to CPGs for loco-regional treatment of sarcomas was associated with worse prognosis in patients with non-metastatic tumors.
[Show abstract][Hide abstract] ABSTRACT: Estrogen receptor (ER) expression is the main indicator of potential responses to endocrine therapy (ET), and approximately 70% of human breast cancers (BCs) are hormone-dependent and ER-positive. The introduction of adjuvant systemic therapy led to a significant improvement in post-surgical survival and a reduction in disease relapse, especially in women with early BC and those with ER+ tumors, who may receive ET alone or in combination with cytotoxic therapy. Adjuvant ET currently consists of (i) ovarian suppression, (ii) selective estrogen receptor modulators (SERMs) and down-regulators, and (iii) aromatase inhibitors (AIs). In patients with ER+ tumors pharmacologic ovary suppression with gonadotropin-releasing hormone agonists in combination with standard adjuvant therapy is generally more effective than adjuvant chemotherapy alone. Tamoxifen is the best established SERM, has favorable effects on BC control and bone metabolism, but also has adverse effects due to its estrogenic activity in other tissues. For these reasons, other SERMs have been developed. Fulvestrant is an ER down-regulator with several potential advantages over SERMs, including a 100-fold increase in its affinity for ER compared with tamoxifen and no estrogen-like activity in the uterus. The inhibition of the aromatase system with third-generation AIs is associated with improved survival in patients with advanced BC compared with SERMs. In postmenopausal patients with ER+ BC adjuvant treatment with AIs should be performed, either as sequential treatment after tamoxifen or as upfront therap y. Studies evaluating the role of AIs as first-line therapy are ongoing and the results are encouraging.
Current Medicinal Chemistry 02/2013; 20(5):596-604. · 3.72 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Sarcomas of the soft tissue are a heterogeneous, rare and complex group of mesenchymal malignant tumors, accounting for
less than 1% of all adult malignancies and about 10-15% of childhood cancer. Despite local disease control obtained with surgery and
pre- or postoperative radiotherapy, roughly one half of patients with high-grade tumors experience metastatic disease. The adjunction of
chemotherapy, either before or after resection, is not currently viewed as standard practice due to the lack of reproducible impact on survival.
The 1997 SMAC meta-analysis based on individual data from randomized studies confirmed a significant impact of adjuvant chemotherapy
on both local and metastatic relapse, without any significant benefit on survival. Further meta-analyses demonstrated a significant
benefit also in overall survival. Yet, the latest adjuvant EORTC trial was disappointedly negative. To date, adjuvant chemotherapy
may be recommended as a reasonable option for the high-risk individual patient who should be well informed on the possible risks
and benefits of treatment. Also the indications for neoadjuvant chemotherapy remain controversial. A local benefit may be gained, facilitating
surgery, but data on survival are limited and affected by a strong patient selection bias. In order to improve our knowledge on sarcomas
and to offer patients the best of current standards, we strongly recommend that all patients be referred to a sarcoma multidisciplinary
group, under whose supervision they could receive the correct combined-modality management as well as have access to new clinical
trials appropriately stratified for risk and histological and/or molecular subtypes.
Current Medicinal Chemistry 01/2013; 20:613-620. · 3.72 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: We report on the case of a 61-year-old man with a soft tissue malignant myoepithelioma of the second toe of the right foot. After removal of the primary tumor, the patient developed in-transit metastases of the limb that we later treated with limb perfusion, using extracorporeal circulation with complete response. Following the appearance of lymph node metastases, the patient underwent inguinal, iliac and obturator lymphadenectomy. Subsequent pelvis metastases were treated with chemotherapy and radiotherapy, with complete response. Currently, after 3 years, the patient is alive and no evidence of any residual disease is apparent.
Journal of surgical case reports. 01/2013; 2013(12).
[Show abstract][Hide abstract] ABSTRACT: Background
There are no data on the patterns of care and outcome of elderly patients with mRCC treated with sunitinib. In a retrospective study, we assessed the routine use of first-line sunitinib in mRCC patients aged ≥ 70 years.
Patients and Methods
We reviewed the clinical files of 185 patients aged >70 years with mRCC treated with first-line sunitinib in seventeen Italian Oncology Units from February 2006 to September 2011. One hundread twenty-three patients (66.5%) received a standard 50 mg/d 4 wk on/2 wk off regimen (SR), and 62 patients (33.5%) received an adapted regimen (AR) consisting in 37.5 mg/d 4 wk on/2 wk off in 67.7% of cases.
Median age was 74 years. Patients treated with an AR were older than those treated with the SR (P <.0001). In the overall population, the median progression-free survival (PFS) was 11 months, and the median overall survival (OS) was 25.5 months. Grade 3-4 toxicities occurred in 70.7% of SR and 51.6% of AR, respectively; dose reductions were required in 66.7% and 41.9%, respectively; discontinuations due to therapy-related adverse events occurred in 20.3% and 24.2%, respectively. In multivariate analysis, only performance status and the Heng score were predictors of either PFS or OS.
Sunitinib is active and feasible in elderly patients with mRCC. A sunitinib AR could be considered as an option in selected older mRCC patients. The optimal treatment of frail patients with mRCC remains to be established.
Clinical Genitourinary Cancer 01/2013; · 1.43 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Background
We conducted a multicenter prospective trial to assess tolerability and activity of pegylated liposomal doxorubicin (PLD) in women ≥ 70 years with locally-advanced or metastatic breast cancer.
Patients and Methods
All patients underwent Multidimensional Geriatric Assessment (MGA). Frail patients were excluded. Normal cardiac function was required for inclusion. A bi-weekly schedule of PLD at 20 mg/mq was adopted.
Thirty-two patients were enrolled with a median age of 78 years, 78.1% with visceral involvement, and 37.6% previously treated with chemotherapy for advanced disease. A mean of 7.8 cycles were delivered (range 1 to 20), with a median cumulative dose intensity of 8.9 mg/m2/week. Grade 3–4 toxicities were anemia (6.3%), palmar–plantar erythrodysesthesia (6.3%), mucositis (6.3%), infection (3.1%), and pulmonary embolism (3.1%). No cardiac events were registered. Causes of treatment interruption were maximal response (15.6%), progression (40.6%), refusal/loss to follow-up (28.1%), toxicities (9.4%), or other (6.3%). Response was obtained in 33.3% of 27 evaluable patients; median time to progression (TTP) was 10.3 months. MGA status (vulnerable vs. fit) did not have an impact on response, progression, and toxicity.
Bi-weekly PLD is well tolerated in both fit and vulnerable patients, with an apparently fairly good response rate and TTP (possibly biased by subsequent endocrine therapy and loss to follow-up). Close observation of patients is recommended in order to avoid early refusal/loss to follow-up.
Journal of Geriatric Oncology 01/2013; 4(4):340–345. · 1.12 Impact Factor