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PubMed1992

Current results of studies of immunophenotype-, age- and leukocyte-based therapy for children with acute lymphoblastic leukemia. The Pediatric Oncology Group.

From February 1986 to January 1991 the Pediatric Oncology Group (POG) treated 2404 children or adolescents with acute lymphoblastic leukemia (ALL) on immunophenotype (T-, B-, Pre-B, or Early pre-B-cell), age, and leukocyte count based treatment protocols (ALinC 14, T-cell 3, B-cell and infant leukemia studies). The immunophenotypic subgroups comprised 78.9% B-precursor cell, 15.1% T-cell, 2.0% B-cell, and 4% infant ALL. Patients with B-progenitor cell ALL were stratified by age and leukocyte count and randomized to receive induction therapy comprised of vincristine, prednisone, and asparaginase with triple intrathecal chemotherapy (methotrexate, hydrocortisone, cytarabine), followed by intensification with moderate-dose MTX (Regimen A), moderate-dose MTX plus asparaginase (Regimen B), moderate-dose MTX plus cytarabine given early (Regimen C), or moderate-dose MTX plus cytarabine given over the first 16 months of therapy (Regimen D). Continuation therapy comprised mercaptopurine and methotrexate with vincristine plus prednisone pulses. Central nervous system preventive treatment was continued for two years. Patients with T-cell or B-cell ALL or infants less than 1 yr old were treated on individual very intensive multiagent therapy protocols. The 4-year event-free survival for all patients was 66.4% +/- 2.4%; B-precursor ALL approximately 72%, T-ALL approximately 50%, B-ALL approximately 60%, and infants less than 1 yr old approximately 16.5%. We conclude that about two-thirds of newly diagnosed children with ALL can be cured with this approach which spares the majority of children exposure to alkylating agents, anthracyclines, epipodophylotoxins, and irradiation, diminishing the risks of serious acute and late effects.

Adolescent↗

PubMed1987

Effective multiagent chemotherapy in children with advanced B-cell lymphoma: who remains the high risk patient?

Between 1981 and 1985, 50 patients, mainly children and adolescents, with advanced B-cell lymphoma were entered on a protocol comprising eight drugs: cyclophosphamide, vincristine, prednisolone, high dose methotrexate, adriamycin, BCNU, cytosine arabinoside and thioguanine. Treatment to the central nervous system consisted of intrathecal methotrexate and cytosine-arabinoside in association with high dose methotrexate without irradiation. Data was collected prospectively with regard to response rate, treatment related complications and survival. Histology was reviewed in all referred cases and in 21 there was supportive evidence from immunological and cytogenetic studies. The overall complete response rate was 86%: 31/36 stage III and 12/14 stage IV. There were four treatment related deaths. The overall disease-free survival is 75% with a median follow up of 32 months. In the group of stage IV patients 5/7 with only marrow involvement, 2/4 with isolated CNS involvement and 1/3 with combined CNS and marrow infiltration survive. All the patients with CNS involvement at presentation underwent consolidation treatment with high dose chemotherapy and bone marrow transplant. These results demonstrate the very high curability of B-cell lymphoma using intensive multiagent therapy even with advanced abdominal disease. Bone marrow infiltration does not appear to be an adverse prognostic factor in isolation from bulk disease or CNS involvement. There remain, however, two groups of patients in whom further intensification of therapy is indicated, namely, those with initial CNS involvement, especially in combination with marrow infiltration, and those with extensive multiorgan involvement at presentation who fail to achieve remission with initial therapy. For the other patients, the large majority, a reduction in the intensity and duration of therapy is currently under study.

Adolescent↗

PubMed1992

Childhood acute lymphoblastic leukemia with both t(1;19) and t(9;22).

The chromosomal rearrangements t(1;19)(q23;p13.3) and t(9;22) (q34;q11.2) are independent abnormalities commonly observed in the blast cells of children with acute lymphoblastic leukemia (ALL). We report three children whose leukemic cells contained both translocations at diagnosis. The patients, two males aged 3 and 8 years and a female aged 14 years, all presented with central nervous system involvement. One patient exhibited a pre-B leukemic phenotype (cytoplasmic immunoglobulin, cIg, positive), while two had an early pre-B phenotype (cIg negative). All three patients received radiotherapy and multiagent chemotherapy which included an epipodophyllotoxin in two patients. Two patients suffered relapses of ALL, in both cases with disappearance of t(1;19)-containing clones but persistence of t(9;22). The two patients who received an epipodophyllotoxin as part of their chemotherapeutic regimen both developed secondary myeloid leukemia with entirely new cytogenetic findings, including abnormalities of chromosome band 11q23. These patients are the first to be described with this unusual combination of cytogenetic abnormalities.

Adolescent↗

PubMed2003

Intensive concurrent chemoradiotherapy for head and neck cancer with 5-Fluorouracil- and hydroxyurea-based regimens: reversing a pattern of failure.

Combined modality programs that were developed over the past two decades demonstrated that the nonsurgical therapy of locoregionally advanced head and neck cancer is feasible and produces survival outcomes that are at least comparable with surgery. The systemic therapy of head and neck cancer has gained momentum in recent years. Several randomized studies have shown that the concurrent administration of chemotherapy and radiation therapy is superior to radiation therapy alone. In consecutive clinical studies since 1986, we have developed multiagent chemoradiotherapy regimens based on initial observations with the 5-fluorouracil (5-FU), hydroxyurea, and concomitant radiotherapy combination. Three consecutive multicenter phase II trials reported that the combination of 5-FU and hydroxyurea with either cisplatin or paclitaxel along with twice daily radiation therapy administered every other week is a highly effective regimen with local control rates that approach 90% and 3-year survival rates of approximately 60% in patients with stage IV disease. The vast majority of patients in these studies achieved anatomical organ preservation. A reversal of the historical pattern of failure was evident, with distant sites becoming the predominant site of failure in each trial. The paclitaxel-containing regimen was better tolerated than the cisplatin-containing regimen and was advanced to further clinical testing. The incorporation of induction chemotherapy may improve the results of treatment by targeting systemic micrometastatic disease.

Aged↗

PubMed1993

Intraarterial chemotherapy for osteosarcoma: does the result really justify the effort?

The use of multiagent chemotherapy has led to improved survival for osteosarcoma patients. Infusion of cisplatin by the intraarterial route in order to devitalize the primary tumor more effectively has been advocated in this context. While systemic drug levels do not seem to be compromised by this regional approach, the envisioned increase in platinum content of osteosarcoma tissue has not been substantiated. As far as clinical results are concerned, neither a comparison of various protocols including cisplatin by either intraarterial or intravenous application, nor the only controlled study dealing with the subject (COSS 86), were able to demonstrate a correlation between the route of cisplatin administration and tumor response to chemotherapy. Therefore, the use of the intraarterial route for cisplatin treatment of osteosarcoma cannot be considered standard therapy but is still an investigational approach without proven benefits. In addition, the risk of side effects and the increased cost of this procedure should be considered before deciding to use intraarterial treatment for osteosarcoma.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed1989

High-risk metastatic gestational trophoblastic disease: further stratification into two clinical entities.

Forty-two of sixty-seven patients (62.7%) treated for high-risk metastatic trophoblastic disease achieved and maintained complete remissions. The survival rate was significantly improved in those patients with scores lower than 8 according to a modification of the World Health Organization (WHO) prognostic scoring system. A low score was associated with a higher probability of response to single-agent therapy, although the difference was not statistically significant. The score, however, was significantly associated with response to multiagent chemotherapy with methotrexate, actinomycin D, and cyclophosphamide (P = 0.0004). Therefore, future trials of new combinations of chemotherapy in high-risk patients should be stratified according to the patients' prognostic scores.

Female↗

PubMed1998

Hodgkin's disease in the setting of human immunodeficiency virus infection.

Although Hodgkin's disease (HD) is not usually associated with congenital or acquired immunodeficiency disorders, recent evidence would suggest a statistically significant increase in HD among individuals infected with human immunodeficiency virus (HIV). In the setting of underlying HIV infection, clinical and pathologic characteristics of HD may differ from usual expectations. Thus, 70%-100% of HIV-infected patients with HD present with systemic "B" symptoms. Likewise, disseminated, stage III or IV disease is reported in approximately 75%-90%. Bone marrow is a common site of extranodal HD, occurring in 40%-50%. Complete response rates after multiagent chemotherapy range from approximately 45% to 70%, although median survival has been only in the range of approximately 18 months. Hematologic toxicity from multiagent chemotherapy may be substantial, even with the use of hematopoietic growth factor support. It is apparent that new strategies of therapeutic intervention must be explored.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed1993

A phase II trial of ifosfamide in previously untreated children and adolescents with unresectable rhabdomyosarcoma.

BACKGROUND: Children and adolescents with unresectable rhabdomyosarcoma fare poorly when treated with contemporary chemotherapeutic regimens. Evaluation of newly developed agents in these patients is important to improve their outcome. Based on a preclinical rhabdomyosarcoma xenograft model that accurately predicted the activity of new agents, the safety and efficacy of ifosfamide was evaluated as part of a Phase II clinical trial in previously untreated children with unresectable rhabdomyosarcoma. METHODS: Twenty-two children and adolescents (median age, 9 years) with newly diagnosed unresectable rhabdomyosarcoma (Intergroup Rhabdomyosarcoma Study Group III [n = 15] or IV [n = 7]) received two courses of ifosfamide at a dose of 1.6 g/m2 intravenously for 5 days over a 6-week period. Then the patients were evaluated for response, and additional treatment with surgery, radiation therapy, and multiagent chemotherapy (vincristine, cyclophosphamide, dactinomycin, and doxorubicin) was administered. RESULTS: Nineteen of 22 patients (86%) had a partial response to ifosfamide given as a single agent. No complete responses to this agent alone were observed. After administration of additional chemotherapy and local control measures (radiation therapy and surgery), the estimated proportion of patients surviving progression-free at 2 years was 63% (95% confidence interval, 37-80%). Ifosfamide was tolerated well; the most frequent toxicity was nondose-limiting myelosuppression. Transient mild renal toxicity infrequently was observed, and no central nervous system toxicity occurred in this group of patients. CONCLUSIONS: Ifosfamide appears to have significant clinical activity in untreated patients with unresectable rhabdomyosarcomas. These findings provide an accurate estimate of the response rate to single-agent ifosfamide in this group of previously untreated patients and thus provide a foundation for its rational incorporation into multiagent clinical trials. In addition, the potential benefits of this type of new drug development were demonstrated.

Adolescent↗

PubMed2003

Medical management of soft tissue sarcomas.

Local therapies for STS, including aggressive surgical resection and radiation therapy, have improved dramatically over the last 10 years. This has resulted in improvement of important clinical outcomes such as enhanced rates of local control and higher quality of life for patients. Systemic therapy for STS, although efficacious to a certain degree, remains investigational. A major task for oncologists will be to measure accurately the single-agent activity of drugs and to integrate promising agents into multiagent regimens. This approach may allow significant progress in the management of STS in canine and feline patients.

Animals↗

PubMed2003

Generic evaluation methods for disaster drills in developing countries.

Disaster simulations (drills) are widely used throughout the world and are considered a fundamental tool for evaluation and improvement of local disaster response capacity. Despite this, no generally accepted methodology exists for quantitative evaluation of the medical response to a disaster drill. We therefore set out to develop and prospectively test a comprehensive method to assess both medical provider and organizational performance during a disaster simulation. Because disasters disproportionately affect the populations of developing countries, we designed these methods to be sufficiently flexible to be applicable in both the developed and the developing world. Objective outcome measures were identified for each component of disaster medical response and were incorporated into 3 data collection instruments. The derived methods were applied to a multiagency disaster simulation in Guatemala City, Guatemala. On the basis of this pilot study, suggested modifications and recommendations were made. The ability to objectively identify the specific strengths and weaknesses of an emergency medical services systems' medical response to a disaster is an important step toward optimizing system performance. On the basis of our experience, we recommend the incorporation of objective evaluation methods such as these into every disaster simulation.

Data Collection↗

PubMed1987

Results of treatment of stage 3A Hodgkin's disease.

From 1975 to 1981, 38 patients with Stage 3A Hodgkin's disease (35 patients pathologically staged) underwent mantle and para-aortic irradiation, and in 36 patients this was preceded or followed by at least six cycles of multiagent chemotherapy. Both the 5-year actuarial survival and disease-free survival for all 38 patients were 83%. There have been six treatment failures: two patients have relapsed within irradiated nodal groups, one patient in apical pericardial lymph nodes as a marginal recurrence, one patient concurrently infield and in unirradiated nodal groups, and two patients systemically (concurrently in unirradiated nodal groups). Of these six relapses, three patients have died of Hodgkin's disease, one patient has been salvaged, and two patients currently are under treatment for salvage. One patient has developed acute nonlymphocytic leukemia and died of this disease. Extensive disease, as estimated by the number of sites of involvement at presentation, degree of splenic involvement, extent of intra-abdominal disease or mediastinal involvement, did not reveal statistically significant prognostic subgroups for relapse. It is currently recommended that patients with Stage 3A Hodgkin's disease receive six cycles of multiagent chemotherapy and mantle and para-aortic irradiation.

Actuarial Analysis↗

PubMed1994

Gliomas in patients with acquired immune deficiency syndrome.

BACKGROUND: Ten percent of patients with acquired immune deficiency syndrome (AIDS) have intracerebral mass lesions of which the majority are due either to toxoplasmosis or primary central nervous system lymphomas. METHODS: Three patients with AIDS presented with solitary intracerebral mass lesions and were found by pathologic examination to have gliomas. RESULTS: After surgery, all patients were treated with radiotherapy and procarbazine, comustine, and vincristine multiagent chemotherapy. Median follow-up is 12 months. CONCLUSIONS: Occasionally, patients with AIDS and intracerebral mass lesions have primary nonlymphomatous brain tumors, an occurrence not related clearly to underlying immunoincompetence.

Acquired Immunodeficiency Syndrome↗

PubMed2006

Dissemination of adjuvant multiagent chemotherapy and tamoxifen for breast cancer in the United States using estrogen receptor information: 1975-1999.

BACKGROUND: Clinical trials have shown tamoxifen to be effective only in women with estrogen receptor (ER)-positive tumors. In a previous model, trends in the utilization of adjuvant therapy were modeled only as a function of age and stage of the disease and not ER status. In this paper, we integrate this previous estimate on the use of adjuvant systemic therapy for breast cancer in the United States with information on ER status from the Patterns of Care (POC) data to estimate the dissemination of adjuvant therapy for women with different ER-status tumors. We also summarize efficacy of adjuvant systemic therapy reported in the overviews of early breast cancer clinical trials. These two inputs, dissemination and efficacy, are key pieces for models that investigate the effect of breast cancer adjuvant therapy on the decline of U.S. breast cancer mortality. METHODS: The adjustments to the previous models are calculated using the POC data on 7116 women with breast cancer diagnosed from 1987 to 1991 and in 1995 who were randomly selected from the Surveillance, and Epidemiology, and End Results (SEER) program registries. The POC data provide more accurate information on treatment and clinical variables (e.g., ER status) than the SEER data because medical records are reabstracted and further verified with treating physicians. RESULTS: Use of multiagent chemotherapy is higher for younger women (<50 years) and for women whose tumors were shown to be ER negative or borderline. The use of tamoxifen is higher among older women and women with ER-positive tumors. After 1980 the combined use of multiagent chemotherapy and tamoxifen for women diagnosed with breast cancer at ages 69 or younger increased more for women whose tumors were ER status positive or unknown than ER status negative. Older women (>69 years) seem to receive almost exclusively tamoxifen irrespective of ER status, except for a small percentage of those with more advanced stages (II- and II+/IIIA) who also receive multiagent chemotherapy. DISCUSSION: The estimated dissemination trends by ER status, based on modeling the POC data, reveal that treatment strategies with demonstrated efficacy in clinical trials have been adopted into practice. The dissemination and efficacy are the two factors necessary to input into models to determine the population impact of these therapies on U.S. breast cancer mortality. The largest decline in mortality would be expected for younger women (<60 years) with ER-positive tumors or whose tumors are of unknown status because of the largest efficacy and dissemination of adjuvant therapy in this group.

Aged↗

PubMed2004

Evidence supporting preoperative chemotherapy for small cell carcinoma of the bladder: a retrospective review of the M. D. Anderson cancer experience.

PURPOSE: Neuroendocrine tumors of the bladder comprise a small subset of all bladder tumors. To improve our understanding of this tumor and define outcomes with current management, we performed a retrospective review of these cases. MATERIALS AND METHODS: We reviewed the records of 88 patients with small cell bladder carcinoma evaluated at our institution between 1985 and 2002. Of these patients 46 underwent cystectomy, including 25 who were treated with initial cystectomy and 21 who received preoperative chemotherapy. RESULTS: For patients treated with initial cystectomy median cancer specific survival (CSS) was 23 months, with 36% disease-free at 5 years. For patients receiving preoperative chemotherapy median CSS has not been reached (p = 0.026), although CSS at 5-years was 78% with no cancer related deaths observed beyond 2 years. Notably 7 of 25 patients treated with initial cystectomy received chemotherapy after surgery but their survival was no better than those treated with cystectomy alone. As others have observed, the pathological stage was higher than clinically appreciated for 56% of patients treated with initial cystectomy. Moreover, there were no cancer related deaths among patients with disease down staged to pT2 or less. CONCLUSIONS: Like other neuroendocrine tumors, small cell carcinoma of the bladder grows rapidly but is chemo-sensitive. Clinical under staging is the rule. Optimal results are achieved via integration of local and systemic treatment. Our results suggest that preoperative chemotherapy is the optimal strategy, even in the setting of clinically localized cancer. On the basis of these observations, we have initiated a trial in which 4 cycles of aggressive multiagent preoperative chemotherapy are followed by radical cystectomy.

Adult↗

PubMed2005

Case report: Reconstruction of an intercalary defect with bone transport after resection of Ewing's sarcoma.

We report a 13-year-old girl with Ewing's sarcoma of the tibia who was treated with multiagent chemotherapy, followed by local control tumor surgery consisting of wide resection of the tumor and bone transport with distraction osteogenesis for reconstruction. The bone defect created by resection was 13 cm long and was replaced by bone transport using a monolateral external fixator. Evaluation of the resected specimen revealed wide tumor-free margins with 100% chemonecrosis. A planned Harmon-type autogenous bone grafting between the middle and proximal segments of the tibia (docking site) was done primarily after docking occurred, and a solid union was obtained by 23 months after resection. The bone healing index (treatment index) was 54 days/1 cm distraction, which is indicative of slow healing. Clinical evaluation of the affected extremity using the Musculoskeletal Tumor Society rating system revealed 80% normal functional capability. Indications for bone transport in reconstruction of bone defects created by wide resection of bone sarcomas are discussed. In retrospect, we have concerns regarding the suitability of this technique in the setting of diaphyseal sarcoma reconstruction in patients with Ewing's sarcoma who require aggressive and intense multiagent chemotherapy.

Adolescent↗

PubMed2000

Issues in the local control of rhabdomyosarcoma.

BACKGROUND: Rhabdomyosarcoma (RMS) is a heterogeneous disease consisting of several different histologies arising from a variety of anatomic sites. Approximately half of the children who die of this tumor have failure at the primary site of involvement, making local control an important component of therapy. PROCEDURE: Published literature and newly analyzed data from the Intergroup Rhabdomyosarcoma Study Group (IRSG) regarding local control of RMS were reviewed. Information regarding the role of various local control modalities for different primary disease sites is presented along with new directions for clinical research. RESULTS: Local control rates for RMS average 80% for group III tumors, with large variations seen for different anatomic sites. Important gains in functional outcome for certain sites such as gynecologic system and bladder/prostate have been achieved by optimizing the use of the various treatment modalities. Local control at other sites such as the chest and extremities remains a problem. CONCLUSIONS: Advances in surgical and radiotherapy techniques coupled with multiagent chemotherapy are providing improved local control with decreasing morbidity. Optimal outcome is dependent on close collaboration between surgical, radiotherapy, and pediatric oncology specialists.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed2006

Primary CNS lymphoma.

Primary CNS lymphoma (PCNSL), an uncommon form of extranodal non-Hodgkin's lymphoma (NHL), has increased in incidence during the last three decades and occurs in both immunocompromised and immunocompetent hosts. PCNSL in immunocompetent patients is associated with unique diagnostic, prognostic, and therapeutic issues, and the management of this malignancy is different from that of other forms of extranodal NHL. Characteristic imaging features should be suggestive of the diagnosis, avoidance of corticosteroids, if possible, and early neurosurgical consultation for stereotactic biopsy. Because PCNSL may involve the brain, CSF, and eyes, diagnostic evaluation should include assessment of all of these regions as well as screening for possible occult systemic disease. Resection provides no therapeutic benefit and should be reserved for the rare patient with neurologic deterioration due to brain herniation. Whole-brain radiation therapy (WBRT) alone is insufficient for durable tumor control and is associated with a high risk of neurotoxicity in patients older than age 60. Neurotoxicity typically is associated with significant cognitive, motor, and autonomic dysfunction, and has a negative impact on quality of life. Chemotherapy and WBRT together improve tumor response rates and survival compared with WBRT alone. Methotrexate-based multiagent chemotherapy without WBRT is associated with similar tumor response rates and survival compared with regimens that include WBRT, although controlled trials have not been performed. The risk of neurotoxicity is lower in patients treated with chemotherapy alone.

Central Nervous System Neoplasms↗

PubMed1986

Modified Bagshawe's regimen in high-risk gestational trophoblastic disease.

Fifty patients with high-risk gestation trophoblastic disease received primary multiagent chemotherapy (CHAMOMA). Forty-one patients (82%) achieved sustained completed biochemical remission. The importance of recognizing the high-risk factors and the effectiveness of primary multiagent chemotherapy are demonstrated.

Adult↗