December 20, 2008 by bmirtsching
Tags: Cancer Research, Cancer Studies, Cancer Treatment, Cancer Trials, Clinical Research, Clinical Trials, Dallas, Drug Studies, Oncology Studies, Oncology Trials, Research, Texas, Treatment, Trials
Posted in Clinical Trials at CORT: Brochure | 1 Comment »
November 12, 2008 by bmirtsching
Melanoma, malignant cancer of the pigmented cells (melanocytes), has increased in incidence. This cancer is the most serious form of skin cancer, with a higher likelihood of recurrence or metastatic spread than other forms of skin cancer. Other less common sites for origination of melanoma include the pigmented layer of the retina, or mucosal areas such as the rectum. Principle treatment is surgical, with wide excision. The extent of local disease is defined by the T stage (tumor depth of invasion), and the N stage (presence of nodal involvement). TNM staging for melanoma may be found at http://en.wikipedia.org/wiki/Melanoma. Nodal staging is important in defining overall stage, so resection of lymph nodes to determine involvement has become a standard practice, in patients other than the shallowest depths of invasion (with more significant chances of nodal involvement). The risk of lymph node sampling may include lymphedema, so sampling of nodes by selective means (sentinel lymph node dissection) is often employed first, with full regional lymphadenectomy reserved for cases with initially positive sentinel lymph nodes. Patients with positive lymph nodes and no other evidence of metastatic disease spread are Stage III in overall stage. The 5-year survival for Stage III disease ranges from 25-60%, depending on the extent of involvement.
Efforts to improve the outcome of Stage III melanoma patients have focused on immunotherapy, because adjuvant radiation or chemotherapy have not improved outcome. High dose Interferon-alpha-2b (Intron-A) has been studied in large, randomized placebo-controlled adjuvant Phase III studies (ECOG 1684, ECOG 1690). Lower doses have also been studied in other randomized clinical trials. An overview of the results of those randomized studies has been published (http://jco.ascopubs.org/cgi/content/full/20/7/1818). The ECOG studies reported improvement in disease free survival (DFS), and the ECOG 1684 study reported an overall survival (OS) improvement that was not confirmed in other studies. Interferon therapy has potentially serious toxicities, including abnormal liver functions, rash, fatigue, anemia, thrombocytopenia, leukopenia, abnormal thyroid function, and exacerbation of autoimmune phenomena. Many patients are unable to complete interferon therapy at high dose, and the value of low dose therapy is not as certain. In the ECOG interferon protocol, continuation of lower dose interferon continues for up to one year, and many patients are unable to complete the duration of therapy. Studies utlizing a newer form of interferon (pegylated interferon alpha, the EORTC Trial 18991) have been reported more recently (ASCO 2007 Annual Meeting, Abstract 8504). That study demonstrated reduced relapse, but again, survival was not improved. Overall, the conclusion can be reached that Stage III melanoma patients should be offered interferon therapy, or a clinical trial of new treatment.
Ipilimumab (MDX-010, Anti-CTLA4) is an antibody therapy that activate the immune response against melanoma. Ipilimumab has been studied in patients with metastatic melanoma, and responses have been seen in 13% of patients treated, some of which were fairly durable. The response rate appears to be somewhat higher than that of interferon in metastatic patients.
Therefore, ipilimumab has entered testing for adjuvant therapy of Stage III melanoma. This study is the BMS CA184-029/EORTC 18071 study http://clinicaltrials.gov/ct2/show/NCT00636168. Patients with completely resected melanoma, with adequate lymph node dissection staging, good performance status, and absence of autoimmune disease are potential candidates. Patients may not have received other adjuvant therapy for disease, and they must enter the study and be randomized within 12 weeks of surgery. Other inclusion and exclusion criteria do apply. The study is placebo controlled. CORT has been selected as a participating site in this trial. For more information on the study, visit the CORT website (www.CORTPA.com), or contact a Research Coordinator at 972-566-5588.
Tags: adjuvant therapy, anti-CTLA4, BMS CA184-029, EORTC, EORTC 18071, immunotherapy, interferon, Intron, Intron-A, Ipilimumab, MDX-010, Melanoma, Stage III
Posted in Melanoma | Leave a Comment »
February 26, 2009 by bmirtsching
A study published in the April 1 issue of Cancer shows that colorectal cancer patients who seek out information about their therapy from media sources (internet, TV, etc.) are more likely to receive new therapies that those who do not. The study was conducted by the Dana Farber Cancer Institute, with lead investigator Dr. Stacey Gray. The study collected information from 633 patients in the Pennsylvania Cancer Registry. Those patients who sought information were 2.8 times more likely to have heard about newer treatments for their disease, and they were 3.2 times more likely to receive those therapies. While the study does not examine outcomes of those patients, outcomes of patients who have received newer treatments for colon cancer are likely to be superior to those who have not.
This study finding is somewhat intuitive. At the CORT research center, we have observed the influence of patient education on treatment selection for quite some time. Patients who have sought out more information about their therapy have come for consultation have in many instances been offered new cancer therapy agents or trial participation options that were not initially suggested in their initial consultatons. The evidence that new agents (cetuximab, bevacizumab, panitumumab) have improved the outcomes of survival in colon cancer is now unequivocal. Information-seeking patients will continue to be more apt to receive the next generation of new agents.
CORT is currently investigating the use of genetic and molecular markers to select patients for adjuvant therapy of Stage II colon cancer (ECOG 5202 Study), the use of cetuximab (Erbitux) in combination with FOLFOX therapy in Stage III colon cancer patients with wild-type k-ras mutation status (N0147 Study), and the comparison of the relative benefit of bevacizumab (Avastin) versus panitumumab (Vectibix) in combination with FOLFOX therapy as first-line treatment of metastatic colon cancer patients with wild-type k-ras mutations status. The thrust of the investigations at CORT is to seek more information that will allow treatments to be more individualized to the patient disease characteristics, since colon cancers are not all the same, even though they may have similar appearances when analyzed by conventional methods.
For more information about colon cancer therapy, visit out website at www.CORTPA.com. For requests for consultation, contact CORT at 972-566-5588 (Dallas) or 972-981-4012 (Plano).
Tags: Clinical Trials, colon cancer, E5202 Study, N0147 Study, patient education, targeted therapy
Posted in Colorectal Cancer | 2 Comments »
January 31, 2009 by bmirtsching
On December 19, 2008, the FDA approved use of imatinib (Gleevec) for adjuvant therapy of resected adult GIST (GI Stromal Tumor).
GISTs are tumors of the bowel wall that originate in the interstitial cells of Cajal, part of the autonomic cell network that control movement of food and fluids through the bowel. GIST occurs in 5000-6000 patients per year in the US. The tumors have an appearance often confused with other bowel wall smooth muscle tumors, known as leiomyomas or sarcomas. GISTs have mutations of cell surface proteins that activate cell proliferation, primarily in the cellular gene c-kit, but also in PDGFRA (platelet derived growth factor receptor-A). Common mutations are in exon 11 and exon 9 of the c-kit gene. Imatinib was found to inhibit the activation of c-kit in patients (those with imatinib-sensitive mutations), and it was approved in 2001 by the FDA for treatment of metastatic GIST, after clinically-meaningful responses (overall approximately 40% of patients have radiographic responses by CT scan, compared to historical responses seen in only 0-5% of chemotherapy-treated GIST) and disease control was demonstrated in early studies. Further investigation has shown that imatinib improves progression-free survival (PFS). The PFS has ranged between 17-24 months in metastatic GIST, depending on the dose of imatinib. Significant differences in response and PFS with imatinib therapy have been established for differing mutations in c-kit (and PDGFRA).
The use of imatinib for adjuvant therapy (post-resection treatment) after complete resection of GIST tumors (when patients have no other apparent disease) was studied in the ACSOG Z9001 study. This was a randomized, double-blind study of imatinib for patients with GIST at high risk for recurrence after resection. The study enrolled 644 patients, and it was stopped in 2007, after a significant improvement in PFS was determined for patients receiving adjuvant imatinib therapy (400 mg/d x 12 months). After 18 months of median follow-up, PFS was 97% in the imatinib group versus 83% in the placebo group. The improvement in PFS was seen across a broad range of tumor size.
Therefore, patients who have had surgery for GIST should now receive at least one year of adjuvant imatinib therapy. The duration of imatinib therapy continues to be studied in other ongoing investigations. It is very important for patients with GIST tumors to be correctly identified when resection occurs, so the benefit of adjuvant therapy is not potentially missed. The CD117 stain may help to differentiate GIST from other soft tissue tumors of the bowel. However, there have been reports of CD117-negative GISTs. PDGFRA staining may also prove helpful. Molecular genetic analysis of c-kit and PDGFRA may not only help to identify patients with GIST, but because certain mutations in these genes is associated with imatinib resistance, testing may serve to help assess the potential benefit of therapy, as other drugs have been developed that have activity in imatinib-resistant forms of GIST. These specialized tests may be obtained by consultation and specimen referral to specialized pathology labs. Such testing can be done on archival tumor tissue. For example, tumor tissue may be sent for analysis at MD Anderson Pathology Lab. A requistion form and instruction is here in the attachment:
MD Anderson Pathology Requisition
Other labs that have experience in testing GISTs:
A review of expanding information about GIST therapy is beyond the scope of this brief post. Additional information is available through GIST support groups (www.liferaftgroup.org, www.gistsupport.org, www.gistinfo.org). Patients who are interesting on medical oncology consultation at CORT may call 972-566-5588. Information about CORT is available at our website: www.CORTPA.com.
Tags: adjuvant therapy, c-kit, GI Stromal Tumor, GIST, Gleevec, Imatinib, mutation testing, PDGFRA
Posted in GIST | 1 Comment »
January 28, 2009 by bmirtsching
CORT has opened a phase I-II study of sapacitabine for second-line therapy of unresectable advanced or metastatic non-small cell lung cancer (NSCLC). Sapacitabine is an oral nucleoside analog prodrug that acts through a dual mechanism. The compound interferes with DNA synthesis by causing single-strand DNA breaks and induces arrest of the cell division cycle at G2 phase.
Both sapacitabine and its major metabolite, CNDAC, have demonstrated potent anti-tumor activity in both blood and solid tumors in preclinical studies. In a liver metastatic mouse model, sapacitabine was shown to be superior to gemcitabine (Gemzar®; Lilly) or 5-FU, two widely used nucleoside analogs, in delaying the onset and growth of liver metastasis.
A number of clinical trials are evaluating sapacitabine in both solid and hematological tumors to establish a foundation for future Phase 2 studies and combination studies with other anti-cancer agents. Three Phase 1 studies have been completed, which evaluated safety and pharmacokinetics of a variety of dosing schedules in approximately 120 patients with solid tumors. Sapacitabine is currently being evaluated in Phase 2 trials in patients with advanced cutaneous T-cell lymphoma (CTCL), in elderly patients with acute myeloid leukemias (AML), and in therapy of NSCLC.
For more information about the CORT study in NSCLC, contact a CORT Research Coordinator at 972-566-5588 (Dallas), or 972-981-4012 (Plano). Addtional information may be found at the CORT website: www.CORTPA.com.
Tags: clinical trial, Locally Advanced, Metastatic, non-small cell lung cancer, NSCLC, nucleoside analogue, oral drug therapy, sapacitabine, second-line
Posted in Lung Cancer | 1 Comment »
January 12, 2009 by bmirtsching
Paclitaxel (Taxol) chemotherapy in combination with Bevacizumab (Avastin) has become a standard treatment regimen for her-2 negative patients with metastatic breast cancer, based on findings of improved outcomes with the combination in the ECOG 2100 study. That trial compared paclitaxel alone to paclitaxel and bevacizumab combination therapy. For the combination, response rate was improved (30% vs. 14%, p<0.0001) and progression-free survival was improved (11.4 mos. vs. 6.1 mos; HR=0.51, p<0.0001). Bevacizumab was approved for treatment of metastatic breast cancer based on these results.
Many patients may not be appropriate for the combination of paclitaxel and bevacizumab therapy. Patients who have received prior taxane therapy in the adjuvant setting (particularly with a short disease-free interval to the time of metastatic disease) may increased risk for resistance to taxane therapy. Patients who are diabetic may have exacerbation of diabetes because of corticosteroid premedication required before taxane therapy. Patients with neuropathy may have worsening of neuropathy with taxane therapy.
For these patients, therapy with another chemotherapy agent in combination with bevacizumab may be considered. However, clinical trial data supporting the combination of other chemotherapy agents with bevacizumab is limited, and insurer coverage may be restrictive. An example of an alternative regimen would be gemcitabine (Gemzar) and bevacizumab. No corticosteriod premedications are required for gemcitabine therapy, and there is no risk of neuropathy.
Other important clinical circumstances may make the use of bevacizumab unattractive, such as severe hypertension, angina or recent ischemic events from coronary or cerebrovascular disease, thrombosis risk, bleeding, or the presence of CNS metastatic disease. Bevacizumab may cause proteinuria, increased blood pressure, bleeding, thrombosis, infusion reactions, delayed wound healing, or other rare toxicities (bowel perforation).
For more information about breast cancer therapy and clinical trial information, contact a CORT Research Coordinator at 972-566-5588 (Dallas) or 972-981-4012 (Plano), or visit our website at www.CORTPA.com.
Tags: Avastin, bevacizumab, Breast Cancer, clinical trial, gemcitabine, Gemzar, metastatic breast cancer, V06-031 study
Posted in Breast Cancer | 1 Comment »
January 7, 2009 by bmirtsching
Author: Barry C. Mirtsching, MD (Center for Oncology Research & Treatment, PA, Dallas, TX)
Spinal column metastasis of solid tumors are not uncommon. Most of these tumors are extrdural in location. However, intradural metastases are rare, comprising only 6% of all spinal metastases, involving the subarachnoid space, filum terminale, or spinal cord. Reports of such cases in the English literature are rare. This report reviews a case of a patient with non-small cell lung cancer (NSCLC) who progressed with disease involving the filum terminale. A similar case was reported previously (Su, J-H et al., Tzu Chi Med J; 2005. 17: 421-423.)
Case Description:
A 62 year old white male smoker presented in 6/2007 with cough and was found to have a 4 cm right upper lobe (RUL) tumor, with associated ipsilateral mediastinal lymph node enlargement and right supraclavicular lymphadenopathy. A biopsy of the RUL tumor revealed bronchogenic adenocarcinoma. He was treated with weekly carboplatin +paclitaxel, and concurrent radiotherapy to the involved regions. He then had 4 cycles of full-dose carboplatin and paclitaxel chemotherapy. He had partial respone in his disease by CT scans, but his supraclavicular nodal disease progressed within three months of completion of therapy. He was then treated with pemetrexed for 4 cycles, but his disease continued to progress in the right supraclavicular area. The patient was then treated on an investigational protocol of sunitinib and erlotinib for two months, with further progression of his supraclavicular nodal disease. He developed severe pain in the lumbar area, with radiation to his bilateral lower extremities. He did not have bowel or bladder disturbance. He had mild hypoaesthesia in his pelvis and lower extremities, and subjective weakness. The patient was moderately debilitated (ECOG performance status 2) and was losing weight. At this time, the patient came to our Center for evaluation and further care in 7/2008.
Evaluation of his CT scans revealed scar-like density in the RUL and ipsilateral mediastinum and a 2 cm nodule in the left lower lobe. MRI of the spine revealed a mass in the lumbar area below the terminus of the cord, involving the filum terminale. The mass extended in the spinal sac from T2 to T4, without extension into the extradural tissue. The mass was enhancing on T1 imaging with gadolinium (Figure 1, T1 with gadolinium sagital images), and it was easily recognized on T2 images (Figure 2, T2 sagital images). The patient was also found to have a 1 cm right cerebellar metastasis.
Figure 1:

- MRI images T1 with gadolinium
Figure 2:

MRI image T2
The patient obtained pain control with narcotic therapy and radiotherapy to the spinal lesion. His cerebellar metastasis was treated with stereotactic radiosurgery and whole brain radiation. These areas were symptomatically completely controlled (sensory function normalized, no appearance of objective motor weakness) and did not progress for 5 months following completion of treatment.
The patient continued with systemic therapy for his cancer, with stable disease in the supraclavicular region and left lung for 5 months. He sequentially received single-agent docetaxel and single-agent gemcitabine. His disease in the supraclavicular area and lung progressed, and he declined further therapy.
Discussion:
This case illustrates the MRI appearance of an usual intraspinal metastasis of lung cancer involving the filum terminale. Symptoms of pain, hypoaesthesia below the level of the lesion, lower extremity weakness, and bowel or bladder contractile disturbance may be associated with such disease. Treatment with surgical decompresion could be considered for relief of acute neurologic compromise, such as paralysis. However, in this case the lesion was treated with radiotherapy, because of the patient’s poor performance status, progressive systemic disease at other sites requiring chemotherapy, absence of significant motor impairment, and poor predicted short-term prognosis. Radiotherapy was effective for prevention of progressive neural impairment and for pain relief.
Tags: adenocarcinoma, filum terminale, intradural, intraspinal metastases, Lung Cancer, MRI, non-small cell lung cancer, NSCLC, palliative care, radiotherapy, spinal metastases
Posted in Rare Cancer Presentations | 1 Comment »
December 25, 2008 by bmirtsching
CORT has initiated the SWOG S0717 Study for treatment of metastatic renal cancer that has progressed after prior sunitinib (Sutent) or sorafenib (Nexavar) therapy. These treatments are standard first-line treatments. After failure of sunitinib or sorafenib, currently, there is no standard therapy for this disease. The study will evaluate anti-angiogenic drug therapy.
Bevacizumab (Avastin) is a monoclonal antibody against VEGF (vascular endothelial growth factor). VEGF is a key protein that stimulates angiogenesis (new blood vessel growth), when binding to endothelial cell VEGF-receptors (VEGF-R). Inhibition of VEGF by bevacizumab has proven successful in metastatic breast, lung, and colon cancer, settings where bevacizumab has already been FDA-approved for use. MEDI-522 (Etaracizumab, Abegrin) is a monoclonal antibody against integrin molecules (av,b3). Intregins are structural signaling molecules that direct cell movement and attachment, and these are required for new blood vessel growth. Early phase studies have shown that disruption of vascular growth by anti-integrin molecules results in tumor growth arrest.
In the S0717 study, patients with metastatic renal cancer will receive either bevacizumab in combination with a placeo MEDI-522 (inactive), or bevacizuamb in combination with active MEDI-522. All patients will receive active bevacizumab. This study evaluates whether the combination of anti-angiogenic drug therapy is more active than anti-angiogenic therapy with bevacizumab alone.
For more information about this study, call a CORT Research Coordinator at 972-566-5588, or visit our website at www.CORTPA.com.
Tags: Abegrin, Avastin, bevacizumab, Etaracizumab, kidney cancer, MEDI-522, metastatic renal cancer, metastatic renal cell carcinoma, Nexavar, renal cell carcinoma, sorafenib, sunitinib, Sutent, SWOG S0717
Posted in Renal Cancer | 1 Comment »
December 17, 2008 by bmirtsching
Metastatic melanoma remains one of the most difficult to treat malignancies for oncologists. This cancer of the pigmented cells in the skin, mucous membranes, or retina may eventually spread to other sites such as lymph nodes, other skin sites, lung, bone, liver, or brain. The disease is rarely curable at such advanced stage, and treatment with chemotherapy has limited benefits in producing response or remissions. Radiotherapy and surgery may have a limited role in palliation of patients with limited metastatic disease. The most commonly employed chemotherapy agent is dacarbazine (DTIC), which may produce response in up to 20% of patients, with responses lasting between 3 and 6 months. Addition of other chemotherapy drugs to DTIC have not significant improved survival outcomes. While immunotherapy with interferon-alpha (IFN) or interleukin-2 (IL-2) may rarely produce a longer lasting remission, the general response rate is not greater than 10-15%, and toxicities are substantial.
Important advances in the understanding of melanoma cell biology have been made. Certain genetic alterations within melanoma cells may trigger or sustain the growth of the cells. The intracellular signaling proteins b-raf and N-ras are activated in about 60% of melanomas, which promotes cell growth. Tumors with these mutations (compared to those without) have a shortened clinical course (worsened prognosis). Research has shown that mutation of either b-raf or N-ras appears to be mutually exclusive in an individual melanoma. Ras protein localizes to the cell membrane by farnesylation of the protein by the enzyme farnesyl transferase. This is an important step in the activation sequence of ras protein.
Loss of function of PTEN (phosphatase and tensin homologue on chromosome 10) is also seen in melanoma. This leads to activation of the Akt and mTor. This alteration may be present in 30-60% of melanoma.
New drugs have been developed that inhibit these intracellular signaling proteins. Sorafenib (Nexavar), an oral agent already approved for treatment of renal cancer, inhibits b-raf. CCI-779 (temsirolimus, Torisel), is an IV agent that has already gained approval for treatment of renal cancer. It inhibits mTor. R115777 (tipifarnib) is an oral agent that blocks farnesyl transferase.
The SWOG S0438 Study open at CORT tests two combinations of these drugs in patients with metastatic melanoma that has not been previously treated. The first combination will be sorafenib and temsirolimus. The second combination tests sorafenib and tipifarnib. Patients will be randomly assigned between the two therapies. Patients must have measurable disease, no brain metastases, and a history of mucosal or cutaneous primary melanoma. Occular melanoma is not eligible for this study.
For more information about this study, contact a CORT Research Coordinator at 972-566-5588, or visit our website at www.CORTPA.com.
Tags: b-raf, CCI-779, clinical trial, Melanoma, metastatic melanoma, mTor, Nexavar, PTEN, R115777, Ras, sorafenib, Stage IV, SWOG S0438, temsirolimus, Tipifarnib, Torisel
Posted in Melanoma | 1 Comment »
December 10, 2008 by bmirtsching
Low-grade follicular B-cell lymphoma is diagnosed in 30,000 US patients each year. The disease is most often diagnosed at an advanced stage, and there is no know curative treatment in such patients. Older therapy, which included alkylators such as cyclophosphamide, produces response and remissions. Cyclophosphamide is often given in combination with other drugs such as vincristine (Oncovin) and prednisone, known as the CVP regimen. Rituximab (Rituxan), is a monoclonal anti-CD20 antibody. CD20 is present on mature B-cells, including low-grade lymphoma. Rituximab therapy is now extensive used alone or in combination with chemotherapy for treatment of low-grade B-cell lymphoma. It is FDA-approved in combination with CVP (R-CVP), following CVP as monotherapy “maintanance”, or at relapse. The use of first-line Rituximab-chemotherapy combinations such was R-CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) has been reported to produce response in 97%, with prolonged remission (median progression-free survival=50 months) (Hiddeman, Blood, 2003).
Relapsed patients have somewhat less responsive disease, and remissions are not expected to be as durable.
Bendamustine (Treanda) received FDA-approval for treatment of relapsed B-cell follicular low-grade non-Hodgkin’s lymphoma on 11/3/08. The approval was based on studies demonstrating a high response rate (74%) and long progression-free duration (median 9.3 months) in patient who received bendamustine therapy for relapse of their disease during or within 6 months of a prior rituximab (Rituxan)-containing treatment regimen. This approval comes within one year of the drug’s initial approval for treatment of chronic lymphocytic leukemia (CLL), another indolent B-cell neoplasm.
The addition of rituximab to bendamustine therapy (R-Treanda) has been studied in a phase II study, producing response in 92% of patients (41% complete responses), with median progression-free survival of 23 months. (Robinson, Journal of Clinical Oncology, 2008).
In addition to offering our patients bendamustine therapy as an option for management, CORT is conducting a trial of rituximab +/- galiximab (anti-CD80 monoclonal antibody). This study will test whether dual antibody therapy improves outcome compared to rituximab alone, for relapsed, but rituximab-sensitive disease.
For more information about bendamustine (Treanda) therapy or lymphoma therapy options at CORT, contact a Clinical Care Coordinator at 972-566-5588, or visit our website at www.CORTPA.com.
Tags: B-Cell Lymphoma, Bendamustine, clinical trial, follicular lymphoma, galiximab, Low Grade, Lymphoma, NHL, Non-Hodgkin's Lymphoma, R-CHOP, rituximab, Treanda
Posted in Lymphoma | 1 Comment »
Sequential Therapies and Integration of Investigational Agents in Treatment of Metastatic Cancer
January 16, 2009 by bmirtschingBroad advances in patient outcomes for patients with metastatic cancers have been noted in the past five years. These improvements have occurred for a number of reasons. Non-oncology physicians have been more active in encouraging patients to engage in therapy for advanced disease. Oncologists have been armed with improved agents that boost response and improve disease control for longer periods, with reduced toxicity of the agents in most cases. Supportive care efforts to minimize treatment risks and toxicities have reduced complications of therapy. Treatment has nearly completely shifted to outpatient oncology infusion centers, improving convenience and lowering costs for treatment delivery.
Clinical trial participation has also contributed to improving care and patient outcomes. While a specific therapy may not always have an evident benefit in survival for an individual patient, the integration of new therapies by clinical trial participation may extend survival compared to sequential therapy with standard approved therapies alone. That may be conceptually understood by the example below, where integration of trial agents X, Y, and Z to existing standard therapy with agents A, B, and C have improved survival expectations. In this hypothetical example, the trial agents have had benefit. However, even if an individual agent does not produce improvement, the sequential integration of such agents into the existing standard treatment paradigm gives the patient an expanded opportunity for having meaningful control of disease and improved survival.
Hypothetical Example of Improved Survival by Integration of Investigational Drugs (X,Y,Z) to Existing Standard Therapy (A,B,C)
Such an approach has been the overlying theme of treatment at the Center for Oncology Research & Treatment (CORT) for over a decade. At CORT, we plan our participation in clinical investigations with the premise that a patient may have a sequence of standard and investigational programs, such that failure of an individual treatment can be followed by another treatment option with cutting-edge new agents that have a significant chance to improve survival for our patients.
For more information about clinical trials at CORT, contact a Clinical Care Coordinator or Research Nurse at 972-566-5588 (Dallas), or 972-981-4012 (Plano), or visit our website at www.CORTPA.com.
Tags: Clinical Trials, investigational therapy, Metastatic, Metastatic Cancer, Sequential Therapy
Posted in Miscellaneous Comments | 1 Comment »