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Craig C Earle

Publications and source records attributed to Craig C Earle.

At least 19 recordsLinked to original sources
PubMed2007

Phase I study of gefitinib, irinotecan, 5-fluorouracil and leucovorin in patients with metastatic colorectal cancer.

PURPOSE: To determine the maximum tolerated doses (MTD), toxicities, efficacy, and pharmacokinetics (PK) of gefitinib combined with irinotecan, 5-fluorouracil (5-FU) and leucovorin (IFL) in patients with previously untreated advanced colorectal cancer. EXPERIMENTAL DESIGN: Starting doses were gefitinib 250 mg/day orally without interruption, irinotecan 100 mg/m(2) as a 90 min intravenous (i.v.) infusion, 5-FU 400 mg/m(2) bolus i.v. and leucovorin 20 mg/m(2) i.v. on days 1 and 8 of a 21-day cycle. Dose escalations involved increasing gefitinib to 500 mg then increasing irinotecan to 125 mg/m(2) and 5-FU to 500 mg/m(2). RESULTS: Twenty-four patients received therapy. The starting doses proved to be the MTD, as attempts to increase the dose of either gefitinib or the chemotherapeutic agents resulted in dose-limiting toxicities. Gastrointestinal effects and bone marrow suppression were the principal toxicities; however, only 1/17 (6%) patients treated with the MTD had severe (grades 3-4) diarrhea and severe neutropenia occurred in only two (12%) patients. Partial responses occurred in 10/17 patients receiving the MTD and another five had stable disease. Median progression-free and overall survivals were 12.2 and 26.6 months, respectively. In ten patients treated with the MTD, the steady-state PK of gefitinib was not affected by IFL nor did gefitinib appear to influence the PK of either irinotecan or 5-FU. CONCLUSIONS: Gefitinib can be safely combined with an intermittent weekly schedule of IFL. Evidence of promising activity should encourage further clinical evaluation of epidermal growth factor receptor tyrosine kinase inhibitors, such as gefitinib, combined with multiagent chemotherapy for metastatic colorectal cancer.

Adult↗
PubMed2007

Using economic analysis to evaluate the potential of multimodality therapy for elderly patients with locally advanced pancreatic cancer.

PURPOSE: Development of new and expensive drugs with activity against pancreatic cancer has made economic considerations more relevant to treatment decision-making for advanced disease. Economic modeling can be used to explore the potential of such novel therapies and to inform clinical trial design. METHODS AND MATERIALS: We developed a Markov model to evaluate the cost-effectiveness of radiation plus fluorouracil (RT-FU) relative to no treatment in elderly patients with locally advanced pancreatic cancer (LAPC) and to determine the economic potential of radiation plus gemcitabine (RT-GEM), a novel regimen for this disease. We used the SEER-Medicare database to estimate effectiveness and costs supplemented by data from the literature where necessary. RESULTS: Relative to no treatment, RT-FU was associated with a cost-effectiveness ratio (ICER) of $68,724/QALY in the base case analysis. Compared with RT-FU, the ICER for RT-GEM was below $100,000/QALY when the risk of dying with the new regimen was <85% than with the standard regimen. However, >1,000 subjects would be necessary to demonstrate this level of efficacy in a randomized trial. The ICER of RT-GEM was most sensitive to utility values, and, at lower efficacy levels, to costs of gemcitabine and treatment-related toxicity. CONCLUSIONS: In elderly patients with LAPC, RT-FU is a cost-effective alternative to no treatment. The novel regimen of RT-GEM is likely to be cost-effective at any clinically meaningful benefit, but quality-of-life issues, drug acquisition, and toxicity-related costs may be relevant, especially at lower efficacy levels.

Aged↗
PubMed2006

Patient and treatment factors associated with complications after prostate brachytherapy.

PURPOSE: To assess the prevalence and predictors of complications after prostate brachytherapy in a population-based sample of older men. PATIENTS AND METHODS: We analyzed claims for Medicare-enrolled men older than age 65 years living in Surveillance, Epidemiology, and End Results (SEER) surveillance areas diagnosed with prostate cancer from 1991 to 1999 who underwent brachytherapy as initial treatment. RESULTS: There were 5,621 men who had brachytherapy with at least 2 years of follow-up. A complication diagnosis or invasive procedure occurred in 54.5% of men within 2 years, with 14.1% undergoing an invasive procedure. Urinary, bowel, and erectile morbidity rates were 33.8%, 21.0%, and 16.7%, respectively, and invasive procedure rates were 10.3%, 0.8%, and 4.0%, respectively. On multivariable analysis, combined urinary diagnoses and invasive procedures (obstruction, incontinence, bleeding, fistula) were associated with older age (P < .01), nonwhite race (odds ratio [OR], 1.30; P = .01), low income (OR, 1.74; P < .01), external-beam radiotherapy (EBRT; OR, 0.85; P = .01), androgen deprivation (OR, 1.31; P < .01), later year of brachytherapy (OR, 1.03/yr; P = .02), higher Charlson comorbidity score (P < .01), and prior transurethral resection of the prostate (OR, 1.65; P < .01). Bowel morbidity (bleeding/proctitis, injury) was associated with older age (P = .04), EBRT (OR, 1.46; P < .01), later year (OR, 1.04/yr; P < .01), higher Charlson score (P = .01), and inflammatory bowel disease (OR, 2.60; P < .01). Erectile morbidity was associated with younger age (P < .01), nonwhite race (OR, 1.37; P < .01), AD (OR, 1.18; P = .04), and later year (OR, 1.08/yr; P < .01). Invasive procedure rates declined with later year of brachytherapy (OR, 0.93/yr; P < .01). CONCLUSION: Morbidity after prostate brachytherapy was common, though invasive procedures were required infrequently. Invasive procedures for complications declined during the 1990s, suggesting technical improvement with experience.

Aged↗
PubMed2006

Failing to plan is planning to fail: improving the quality of care with survivorship care plans.

The recent Institute of Medicine report "From Cancer Patient to Cancer Survivor: Lost in Transition" recommended the creation of survivorship care plans for patients as they complete primary therapy for cancer to ensure clarity for all involved about patients' diagnoses, treatments received, and surveillance plans. Any previously existing follow-up guidelines for cancer survivors have been largely restricted to surveillance for recurrence of the primary disease. An important message of the Institute of Medicine report is that survivorship care plans must surpass this and address the chronic effects of cancer (pain, fatigue, premature menopause, depression/anxiety), monitoring for and preventing late effects like osteoporosis, heart disease, and second malignancies, and promoting healthy lifestyles. It should explicitly identify the providers responsible for each aspect of ongoing care and provide information on resources available for psychosocial and other practical issues that may arise as a result of the prior cancer diagnosis. Although having some sort of a plan is clearly necessary to achieve high quality care, there are practical barriers to formal off-treatment consultations and the creation of written documents that may become part of the medical record. This article reviews the elements of the proposed survivorship care plan and discusses areas of research and development needed to make them part of standard oncology practice.

Aftercare↗
PubMed2006

Measuring disease-free survival and cancer relapse using Medicare claims from CALGB breast cancer trial participants (companion to 9344).

To determine the accuracy with which Medicare claims data measure disease-free survival in elderly Medicare beneficiaries with cancer, we performed a criterion validation study. We merged gold-standard clinical trial data of 45 elderly patients with node-positive breast cancer who were treated on the Cancer and Leukemia Group B (CALGB) adjuvant breast trial 9344 with Centers for Medicare and Medicaid Services (CMS) data files and compared the results of a CMS-based algorithm with the CALGB disease-free survival information to determine sensitivity and specificity. For 5-year disease-free survival, the sensitivity of the CMS-based algorithm was 100% (95% confidence interval [CI] = 81% to 100%), the specificity was 97% (95% CI = 83% to 100%), and the area under the receiver operator curve was 98[corrected]% (95% CI = 95[corrected]% to 100%). For 2-year disease-free survival, the test characteristics were less favorable: sensitivity was 83% (95% CI = 36% to 100%), specificity was 95% (95% CI = 83% to 100%), and area under the receiver operator curve was 89[corrected]% (95% CI = 72[corrected]% to 100%).

Aged↗
PubMed2006

Surgical mortality in patients with esophageal cancer: development and validation of a simple risk score.

PURPOSE: Surgery has curative potential in a proportion of patients with esophageal cancer, but is associated with considerable perioperative risks. We aimed to develop and validate a simple risk score for surgical mortality that could be applied to administrative data. PATIENTS AND METHODS: We analyzed 3,592 esophagectomy patients from four cohorts. We applied logistic regression analysis to predict mortality occurring within 30 days after esophagectomy for 1,327 esophageal cancer patients older than 65 years of age, diagnosed between 1991 and 1996 in the linked Surveillance, Epidemiology and End Results (SEER)--Medicare database. A simple score chart for preoperative risk assessment of surgical mortality was developed and validated on three other cohorts, including 714 SEER-Medicare patients diagnosed between 1997 and 1999, 349 patients from a population-based registry in the Netherlands diagnosed between 1993 and 2001, and 1,202 patients from a referral hospital in the Netherlands diagnosed between 1980 and 2002. RESULTS: Surgical mortality in the four cohorts was 11% (147 of 1,327), 10% (74 of 714), 7% (25 of 349), and 4% (45 of 1,202), respectively. Predictive patient characteristics included age, comorbidity (cardiac, pulmonary, renal, hepatic, and diabetes), preoperative radiotherapy or combined chemoradiotherapy, and a relatively low hospital volume. At validation, the simple score showed good agreement of predicted risks with observed mortality rates (calibration), but low discrimination (area under the receiver operating characteristic curve 0.58 to 0.66). CONCLUSION: A simple risk score combining clinical characteristics along with hospital volume to predict surgical mortality after esophagectomy from administrative data may form a basis for risk adjustment in quality of care assessment.

Adult↗
PubMed2006

Frequency and cost of chemotherapy-related serious adverse effects in a population sample of women with breast cancer.

BACKGROUND: The number, nature, and costs of serious adverse effects experienced by younger women receiving chemotherapy for breast cancer outside of clinical trials are unknown. METHODS: From a database of medical claims made by individuals with employer-provided health insurance between January 1998 and December 2002, we identified 12,239 women 63 years of age or younger with newly diagnosed breast cancer, of whom 4075 received chemotherapy during the 12 months after the initial breast cancer diagnosis and 8164 did not. Diagnostic codes for eight chemotherapy-related adverse effects were identified. Total hospitalizations for all causes, hospitalizations or emergency room visits for adverse effects that are typically related to chemotherapy, and health care expenditures were compared between the two groups of women. All statistical tests were two-sided. RESULTS: Women who received chemotherapy were more likely than those who did not to be hospitalized or to visit the emergency room for all causes (61% versus 42%; mean difference = 19%, 95% confidence interval [CI] = 16.7% to 21.3%, P<.001) and for chemotherapy-related serious adverse effects (16% versus 5%, mean difference = 11%, 95% CI = 9.6% to 12.4%, P<.001). The percentages of chemotherapy recipients who were hospitalized or visited the emergency room during the year after their breast cancer diagnosis were 8.4% for fever or infection; 5.5% for neutropenia or thrombocytopenia; 2.5% for dehydration or electrolyte disorders; 2.4% for nausea, emesis, or diarrhea; 2.2% for anemia; 2% for constitutional symptoms; 1.2% for deep venous thrombosis or pulmonary embolus; and 0.9% for malnutrition. Chemotherapy recipients incurred large incremental expenditures for chemotherapy-related serious adverse effects (1271 dollars per person per year) and ambulatory encounters (17,617 dollars per person per year). CONCLUSIONS: Chemotherapy-related serious adverse effects among younger, commercially insured women with breast cancer may be more common than reported by large clinical trials and lead to more patient suffering and health care expenditures than previously estimated.

Adult↗
PubMed2006

Radiation therapy after mastectomy between 1991 and 1999 in elderly women: response to clinical trial information.

PURPOSE: No systematic study has analyzed the changing patterns of use of postmastectomy radiation therapy (PMRT) during the period of information dissemination regarding the benefit of radiation therapy in this setting. We sought to study the receipt of PMRT in elderly women in this period, using a population-based cohort of women with breast cancer. PATIENTS AND METHODS: Using data from the linked Surveillance, Epidemiology, and End Results-Medicare database, we analyzed the use of radiation therapy between 1991 and 1999 in 19,699 women with stage I to III breast cancer who received mastectomy as definitive surgery. Multivariable logistic regression was used to investigate the association of diagnosis year and the use of PMRT, after controlling for clinical and sociodemographic factors. RESULTS: During the entire period studied, 2,160 (11.0%) patients treated with mastectomy received PMRT. The use of PMRT significantly increased in women diagnosed in 1996 (odds ratio [OR], 1.26; P = .04), 1997 (OR, 1.70; P < .0001), 1998 (OR, 1.57; P < .0001), and 1999 (OR, 1.77; P < .0001), relative to those diagnosed in 1991 after controlling for cancer, and sociodemographic and treatment characteristics. There were significant differences in the temporal trends of radiation use among different regions of the country (P < .0001), and between teaching versus nonteaching institutions (P = .04). CONCLUSION: The use of PMRT in elderly women increased significantly during the period of data dissemination about its efficacy; however, the trends in adoption varied among different practice settings.

Aged↗
PubMed2006

Do unto others...

Explore the source record for details and available documents.

Antineoplastic Agents↗
PubMed2006

Effect of distance to radiation treatment facility on use of radiation therapy after mastectomy in elderly women.

PURPOSE: We sought to study the effect of distance to the nearest radiation treatment facility on the use of postmastectomy radiation therapy (PMRT) in elderly women. METHODS AND MATERIALS: Using data from the linked Surveillance, Epidemiology, and End Results-Medicare (SEER-Medicare) database, we analyzed 19,787 women with Stage I or II breast cancer who received mastectomy as definitive surgery during 1991 to 1999. Multivariable logistic regression was used to investigate the association of distance with receipt of PMRT after adjusting for clinical and sociodemographic factors. RESULTS: Overall 2,075 patients (10.5%) treated with mastectomy received PMRT. In addition to cancer and patient characteristics, in our primary analysis, increasing distance to the nearest radiation treatment facility was independently associated with a decreased likelihood of receiving PMRT (OR = 0.996 per additional mile, p = 0.01). Secondary analyses revealed that the decline in PMRT use appeared at distances of more than 25 miles and was statistically significant for those patients living more than 75 miles from the nearest radiation facility (odds of receiving PMRT of 0.58 [95% CI = 0.34-0.99] vs. living within 25 miles of such a facility). The effect of distance on PMRT appeared to be more pronounced with increasing patient age (>75 years). Variation in the effect of distance on radiation use between regions of the country and nodal status was also identified. CONCLUSIONS: Oncologists must be cognizant of the potential barrier to quality care that is posed by travel distance, especially for elderly patients; and policy makers should consider this fact in resource allocation decisions about radiation treatment centers.

Aged↗
PubMed2006

Phase I and pharmacokinetic study of S-1 administered for 14 days in a 21-day cycle in patients with advanced upper gastrointestinal cancer.

PURPOSE: S-1 is a novel oral fluoropyrimidine that combines tegafur with CDHP and oxonic acid. To decrease the incidence of late onset, severe diarrhea observed in a previous study, a phase I study was conducted to determine the maximum tolerated dose (MTD) of S-1 utilizing a 14-day schedule, repeated every 21 days, in patients with chemotherapy-refractory upper gastrointestinal malignancies. METHODS: S-1 was administered orally, twice-daily, at an initial dose level of 30 mg/m2/dose; doses were escalated by 5 mg/m2 at each level. A minimum of three patients were enrolled at each dose level. S-1 toxicity, antitumor activity, and pharmacokinetics were assessed. The MTD was based on the dose limiting toxicity (DLT) during the first treatment cycle. RESULTS: At 30 mg/m2 no DLT was observed in the first three evaluable patients. Two of the first three patients at the 35 mg/m2 dose level developed DLTs (grade 3 rash and dehydration). An additional nine patients were subsequently treated at 30 mg/m2 without DLT and this dose was established as the MTD. Common toxicities at 30 mg/m2 included diarrhea, nausea, skin rash, anorexia, and fatigue. No grade 4 toxicities were observed. One partial response was seen in a patient with gemcitabine-refractory pancreatic adenocarcinoma and ten patients with pancreatic, gastric, or gallbladder carcinomas achieved stable disease as their best response to therapy. The AUC(0-8) of 5-FU at the 30 and 35 mg/m2 dose levels were 875 +/- 212 and 894 +/- 151 h ng/ml, respectively. CONCLUSIONS: In a 14-day dosing schedule, the MTD of S-1 was 30 mg/m2 and preliminary evidence of antitumor activity was seen in a North American population with refractory upper gastrointestinal malignancies.

Administration, Oral↗
PubMed2006

Phase II study of capecitabine, oxaliplatin, and erlotinib in previously treated patients with metastastic colorectal cancer.

PURPOSE: To investigate the combination of erlotinib, capecitabine, and oxaliplatin in patients who were previously treated for metastatic colorectal cancer. PATIENTS AND METHODS: Patients were eligible if they had metastatic colorectal cancer that progressed, were intolerant to first-line chemotherapy, or had disease recurrence within 1 year of adjuvant therapy for early-stage disease. Each 21-day cycle consisted of daily oral erlotinib at 150 mg, oral capecitabine at 1,000 mg/m2 (reduced to 750 mg/m2 after the first 13 patients) twice a day on days 1 to 14, and intravenous oxaliplatin at 130 mg/m2 on day 1. RESULTS: Thirty-two patients were enrolled onto this phase II study. By intention-to-treat analyses, eight patients (25%) experienced a partial response and 14 patients (44%) had stable disease for at least 12 weeks. The median progression-free survival was 5.4 months and the median overall survival was 14.7 months. These results were essentially unchanged when limited to the cohort of patients (78%) who received prior irinotecan for metastatic colorectal cancer. Most common grade 3 to 4 toxicities included diarrhea (38%), nausea/emesis (19%), fatigue (16%), dehydration (16%), and dermatitis (13%); grade 3 or 4 toxicities were reduced with a lower starting dose of capecitabine. CONCLUSION: The combination of capecitabine, oxaliplatin, and erlotinib seems to have promising activity against metastatic colorectal cancer in patients who received prior chemotherapy, with a relatively higher response rate and progression-free survival compared with previous reports of either infusional FU, leucovorin, and oxaliplatin or capecitabine and oxaliplatin in similar patient populations.

Adenocarcinoma↗
PubMed2006

Effect of surgeon specialty on processes of care and outcomes for ovarian cancer patients.

BACKGROUND: For many diseases, specialized care (i.e., care rendered by a specialist) has been associated with superior-quality care (i.e., better outcomes). We examined associations between physician specialty and outcomes in a population-based cohort of elderly ovarian cancer surgery patients. METHODS: We analyzed the Medicare claims, by physician specialty, of all women aged 65 years or older who underwent surgery for pathologically confirmed invasive epithelial ovarian cancer between January 1, 1992, and December 31, 1999, while living in an area monitored by the Surveillance, Epidemiology, and End Results (SEER) program to assess important care processes (i.e., the appropriate extent of surgery and use of adjuvant chemotherapy) and outcomes (i.e., surgical complications, ostomy rates, and survival). All statistical tests were two-sided. RESULTS: Among 3067 ovarian cancer patients who underwent surgery, 1017 patients (33%) were treated by a gynecologic oncologist, 1377 patients (45%) by a general gynecologist, and 673 patients (22%) by a general surgeon. Among patients with stage I or II disease, those treated by a gynecologic oncologist (60%) were more likely to undergo lymph node dissection than those treated by a general gynecologist (36%) or a general surgeon (16%). Patients with stage III or IV disease were more likely to undergo a debulking procedure if the initial surgery was performed by a gynecologic oncologist (58%) than by a general gynecologist (51%) or a general surgeon (40%; P < .001) and were more likely to receive postoperative chemotherapy when operated on by a gynecologic oncologist (79%) or a general gynecologist (76%) than by a general surgeon (62%, P < .001). Survival among patients operated on by gynecologic oncologists (hazard ratio [HR] of death from any cause = 0.85, 95% confidence interval [CI] = 0.76 to 0.95) or general gynecologists (HR = 0.86, 95% CI = 0.78 to 0.96) was better than that among patients operated on by general surgeons. CONCLUSIONS: Ovarian cancer patients treated by gynecologic oncologists had marginally better outcomes than those treated by general gynecologists and clearly superior outcomes compared with patients treated by general surgeons.

Aged↗
PubMed2006

A phase II trial of irinotecan and cisplatin in patients with metastatic neuroendocrine tumors.

The role of systemic chemotherapy in the treatment of patients with metastatic neuroendocrine tumors is controversial. While combination regimens containing cisplatin and etoposide have activity against more aggressive neuroendocrine tumor variants, such regimens appear to have little efficacy in patients with well-differentiated neuroendocrine tumor subtypes. The combination of irinotecan and cisplatin is active both against small cell lung cancer and in upper gastrointestinal malignancies but has not been prospectively evaluated in patients with metastatic neuroendocrine tumors. We therefore assessed the efficacy of an irinotecan/cisplatin combination in patients with this disease. Eighteen patients with metastatic neuroendocrine tumors (excluding small cell carcinoma) were treated with irinotecan, 65 mg/m2, and cisplatin, 30 mg/m2, administered weekly for 2 of every 3 weeks. Patients were followed for evidence of toxicity, response, and survival. The toxicities associated with this regimen were mild and included myelosuppression, nausea, and diarrhea. Only one radiologic response was observed among four patients with poorly differentiated neuroendocrine tumors. No radiologic responses were observed in 14 patients with well-differentiated tumors. The median overall survival duration of patients treated with this regimen was 11.4 months. We conclude that while the combination of irinotecan and cisplatin may have activity in aggressive neuroendocrine tumor subtypes, this combination is inactive in patients with well-differentiated neuroendocrine tumors.

Adult↗
PubMed2006

The combination of capecitabine and thalidomide in previously treated, refractory metastatic colorectal cancer.

BACKGROUND: With the increasing survival of patients with metastatic colorectal cancer (CRC) there is a growing need for effective second- and third-line agents. We conducted a multicenter, phase II study to examine the combination of capecitabine and thalidomide (Cape/Thal) in patients with refractory metastatic CRC. METHODS: Patients with previously treated stage IV CRC were eligible. Treatment consisted of capecitabine at 1,000 mg/m2 po BID for 14 days every 3 weeks and thalidomide, starting at 200 mg po QD continuously. Thalidomide was escalated individually to 600 mg po QD as tolerated. We analyzed overall survival (OS), progression-free survival, response, and toxicity rates. RESULTS: Thirty-four eligible patients were enrolled. The median age was 57 years, and most patients had a normal performance status (65%). All patients had received prior chemotherapy and 19 (56%) had received 2 or 3 prior regimens. The median number of Cape/Thal cycles administered was 3 (range, 1-15). Grade 3/4 toxicities included fatigue (15%), venous thromboembolic events (12%), somnolence (12%), and constipation (9%). Grade 2 hand-foot syndrome occurred in 5 (15%) patients. There were no radiographic responses; 13 patients (38%) achieved stable disease. The median PFS was 2.6 months (95% confidence interval [CI] = 2.2-3.9) and the median OS was 7.1 month (95% CI = 5.2-12.0). CONCLUSIONS: Though well-tolerated, the combination of capecitabine and thalidomide was not associated with objective tumor responses in a population of patients with previously treated metastatic CRC.

Administration, Oral↗
PubMed2006

Towards using administrative databases to measure population-based indicators of quality of end-of-life care: testing the methodology.

This study is concerned with methods to measure population-based indicators of quality end-of-life care. Using a retrospective cohort approach, we assessed the feasibility, validity and reliability of using administrative databases to measure quality indicators of end-of-life care in two Canadian provinces. The study sample consisted of all females who died of breast cancer between 1 January 1998 and 31 December 2002, in Nova Scotia or Ontario, Canada. From an initial list of 19 quality indicators selected from the literature, seven were determined to be fully measurable in both provinces. An additional seven indicators in one province and three in the other province were partially measurable. Tests comparing administrative and chart data show a high level of agreement with inter-rater reliability, confirming consistency in the chart abstraction process. Using administrative data is an efficient, population-based method to monitor quality of care which can compliment other methods, such as qualitative and purposefully collected clinical data.

Breast Neoplasms↗
PubMed2006

Efficacy of cetuximab after treatment with oral epidermal growth factor receptor tyrosine kinase inhibitor-based chemotherapy in metastatic colorectal cancer.

PURPOSE: We studied the efficacy of cetuximab therapy in patients with metastatic colorectal cancer (mCRC) previously treated with an oral inhibitor of the tyrosine kinase domain of the epidermal growth factor receptor. PATIENTS AND METHODS: We reviewed the posttrial records of 73 patients with mCRC who participated in 1 of 3 clinical trials that examined a combination of gefitinib or erlotinib with standard cytotoxic chemotherapy. Medical and pharmacy records were used to identify patients who were subsequently treated with cetuximab-based therapy. Computed tomography scans during cetuximab-based therapy were reviewed, and the clinical activity of cetuximab was assessed by response rate using Response Evaluation Criteria in Solid Tumors and progression-free survival. RESULTS: Twenty-four patients with mCRC previously treated with gefitinib or erlotinib and combination cytotoxic chemotherapy who subsequently received cetuximab-based therapy were identified. While receiving cetuximab-based therapy, no patient experienced a partial or complete response; however, 3 patients (16% of patients with available scans for formal measurements) had a minor response, defined as a 15%-29.9% decrease in the sum of longest dimensions of target lesions, and 72% had stable disease. The progression-free survival was 5.1 months for all patients and 6 months for patients who had documented progression of disease while previously receiving gefitinib- or erlotinib-based therapy. CONCLUSION: Cetuximab appears to have clinical benefit in patients with mCRC previously treated with a chemotherapy regimen that included an oral tyrosine kinase inhibitor of epidermal growth factor receptor. Whether these results apply to other cancer types is unknown but worthy of further study.

Adult↗